DocuSign Envelope ID: F2830FDF-7A1B-4449-B6DD-E8572474DEE0
SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS
OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30
7” REQUISITION NUMBER
5765075
PAGE OF
1 21
2 SONTRAGT NO, [5 AWARD? Js ORDER NUMBER 5. SOLICITATION NUMBER js. SOLICITATION
79N92020C00006 EFFECTIVE DATE Issue DATE
7 FOR SOLICITATION fa. NAME jp. TELEPHONE NUMBER (Wo collect cals) 8. OFFER DUE DATE/LOGAL TIME
INFORMATION CALL: Shirley Ruiz-Lundgren 301-827-7529
‘9. ISSUED BY ‘cone [TO-NHLBI 10. THISACQUISITIONIS UNRESTRICTED OR SET ASIDE: % FOR:
National Institutes of Health ‘SMALL BUSINESS erioea) CLINE VAG TTeS HOG TINNNE.
National Heart, Lung, and Blood HUBZONE SMALL SMAI! RUSINESS PROGRAM
Institutes g. BUSINESS EDWOSB aves: 621524)
Bethesda MD 20892-7511 vonauitinee ww size stanoarp; $32.5
‘SMALL BUSINESS
1, DELIVERY FOR FOB DESTINA- [12 DISCOUNT TERMS 130 RATING
TION UNLESS BLOCK IS, 13a, THIS CONTRACT ISA
MARKED: RATED ORDER UNDER: 14, METHOD OF SOLICITATION
X! SEE SCHEDULE DPAS AE CEB ION) RFQ FB RFP
15. DELIVER TO COE TBLDG 1, BETHMC 16. ADMINISTERED BY ‘CODE JADM-NHLBI
BLDG 1, BETHMC National Institutes of Health
James A. Shannon Building, National Heart, Lung and Blood
BLDG 1, Institute
1 Center Drive Bethesda MD 20892-7511
N/A
Bethesda MD 20892
Fis CTA ‘cove 1079920413 near 180. PAYMENT WILL BE MADE BY CODE NHLBI INV-BR-B
HELIX OPCO, LLC NHLBI Branch B Invoice
Attn: James Lu 2115 East Jefferson St, MSC 8500
101 S Ellsworth Ave Room 4B-432
STE 350 Bethesda MD 20892-8500
San Mateo CA 94401
832-744-7129
‘TELEPHONE NO,
170. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER /18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW
IS CHECKED ‘SEE ADDENDUM
19, 20. 2 22. 23. 24,
ITEM NO, ‘SCHEDULE OF SUPPLIESISERVICES QUANTITY |UNIT UNIT PRICE AMOUNT
Rapid Acceleration of Diagnostics Advanced
Itechnology Platforms (RADx-ATP)
This Letter Contract forms a preliminary
lunderstanding between Helix OpCo,
the National Institutes of Health (NIH)
Diagnostics Advanced Technology Platforms
(Use Reverse and/or Attach Additional Sheets as Necessary)
25. ACCOUNTING AND APPROPRIATION DATA
See schedule
Project #6435: Reproducible clinical test system
for SARS-CoV-2 tests using amplicon sequencing
LLC (Helix) and
and is
issued as a result of the Rapid Acceleration of
(RADx-ATP) to increase the testing capacity of
Ihigh throughput labs by scaling up late stage
TOTAL AWARD AMOUNT (For Govt. Use Only)
$13,022,500.00
27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, §2.212-4. FAR 52.212-3 AND 52.212-5 AREATTACHED. ADDENDA ARE (ARE NOT ATTACHED.
27. CONTRACTIPURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE | ARE NOT ATTACHED.
X28, CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN 1 29. AWARD OF CONTRACT: OFFER
COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER
ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL
SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.
DATED YOUR OFFER ON SOLICITATION (BLOCK 5),
INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH
HEREIN, IS ACCEPTED AS TO ITEMS:
30a,
‘ta: UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)
. : Digitally signed by Shirley Ruiz-
Shirley Ruiz-lundgren -S tundgren-s
Date: 2020.07.30 12:27:15 -04'00'
30c. DATE SIGNED
July 29, 2020
IGNER (Type or print)
Chief scientific officer
James Lu,
[31b. NAME OF CONTRACTING OFFICER (Type or print) [31c. DATE SIGNED
Shirley Ruiz-Lundgren
AUTHORIZED FOR LOCAL REPRODUCTION.
PREVIOUS EDITION IS NOT USABLE
‘STANDARD FORM 1449 (REV. 2/2012)
Prescribed by GSA - FAR (48 CFR) 53.212
DocuSign Envelope ID: F2830FDF-7A1B-4449-B6DD-E8572474DEE0 > ge 21
°
19, 20. 2 22. 23. 24
ITEM NO, ‘SCHEDULE OF SUPPLIESISERVICES ‘quantity | UNIT UNIT PRICE AMOUNT
testing platforms for detecting SARS-CoV-2, the
virus that causes COVID-19. This Letter Contract
is an Undefinitized Contract Action that will be
definitized in accordance with the schedule
contained herein.
Period of Performance: 07/30/2020 to 07/29/2021
De
1 Stage 1 Initiate Scale Up - RADx, COVID 19 1] EA)
Initiative
Delivery: 08/07/2020
Project Data:
151796-2020.100-HNA1 OD IOD IMMEDIATE OFFICE OF
THE DIRECTOR-25235 ALL OTHER SERVICES
(NON-FEDERAL SOURCES) -07/28/2020
Accounting Info:
2 Stage 2 Regulatory Submission, Collection Kit, 1
more - RADx - COVID 19 Initiative
Delivery: 09/01/2020
Continued ...
32a, QUANTITY IN COLUMN 21 HAS BEEN
RECEIVED INSPECTED ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:
32¢, DATE 32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE
32b, SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE
32e, MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE
32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE
37. CHECK NUMBER
33, SHIP NUMBER, [35. AMOUNT VERIFIED 36. PAYMENT
CORRECT FOR
PARTIAL
COMPLETE
PARTIAL
40. PAID BY
38, SIR ACCOUNT NUMBER 139. SIR VOUCHER NUMBER
41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT. |42a. RECEIVED BY (Print)
41b, SIGNATURE AND TITLE OF CERTIFYING OFFICER 1c. DATE
42b. RECEIVED AT (Location)
42d, TOTAL CONTAINERS
‘STANDARD FORM 1449 (REV. 2/2012) BACK
DocuSign Envelope ID: F2830FDF-7A1B-4449-B6DD-E8572474DEE0
FERENCE NO. OF DOCUMENT BEING CONTINUED
CONTINUATION SHEET Frswo2 020c00006
NAME OF OFFEROR OR CONTRACTOR
HELIX OPCO, LLC
ITEM NO,
(A)
‘SUPPLIESISERVICES
(B)
QUANTITY UNIT
(C)
(D)
UNIT PRICE
(E)
‘AMOUNT
(F)
Project Data:
151796-2020.100-HNA1 OD IOD IMMEDIATE OFFICE OF
THE DIRECTOR-25235 ALL OTHER SERVICES
(NON-FEDERAL SOURCES) -07/28/2020
Accounting Info:
08034620200DAD-2020-81-A100-EMHNA10000C-E-C4490-40
6-COVD-25235-9999-9999-9999-151796-2020.100-HNAL
OD IOD IMMEDIATE OFFICE OF THE
DIRECTOR-07/28/2020-25235 ALL OTHER SERVICES
(NON-FEDERAL SOURCES) -8046555
NSN 7540-01-152-8067
‘OPTIONAL FORM 336 (4-86)
‘Sponsored by GSA
FAR (48 CFR) 53.110
DocuSign Envelope ID: F2830FDF-7A1B-4449-B6DD-E8572474DEE0
PART | — THE SCHEDULE
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
ARTICLE B.1. BRIEF DESCRIPTION OF SERVICES
This Letter Contract forms a preliminary understanding between Helix OpCo, LLC (Helix) and the National
Institutes of Health (NIH) and is issued as a result of the Rapid Acceleration of Diagnostics Advanced Technology
Platforms (RADx-ATP) program to increase the testing capacity of high throughput labs by scaling up late stage
testing platforms for detecting SARS-CoV-2, the virus that causes COVID-19. Issuance of this Letter Contract
authorizes the Contractor to immediately begin the activities necessary to perform the requirements as
identified in the Statement of Objectives covering the full range of activities needed to increase capacity and
optimize throughput necessary to distribute a viable product to the public.
The scope of work executed under this contract, includes completing the validation, approval, and production
processes in order to deliver a viable product in a scaled up capacity to the U.S. public. The Helix technology to
support this effort is an amplicon based next generation sequencing (NGS) test intended for the qualitative
detection of nucleic acid from the SARS-CoV-2 in upper respiratory nasopharyngeal (NP), anterior nares (AN) and
oropharyngeal (OP) swab specimens. Using this technology, Helix will scale up testing capacity to 50,000 tests
per day by ian 100,000 tests per day by
This Letter Contract has been issued based on the submissions by the contractor under the RADx-ATP program,
which includes the application and preliminary work file and subsequent documentation submitted during the
review process. The Contractor’s inability to meet the requirements as defined within this Letter Contract and
proposed within the application process may result in the termination of the Letter Contract in accordance with
the termination clauses contained herein.
ARTICLE B.2. PRICES
a. The total Firm Fixed Price (FFP) amount for this Letter Contract is $13,022,500.
b. Pricing Schedule
Milestone Date Description Price
1 8/7/2020 | Stage 1: Initiate Scale Up/EUA Pe)
Authorization of PCR
2 9/1/2020 | Stage 2: Regulatory Submission,
Collection Kit, and 25,000/daily on PCR
ARTICLE B.3. ADVANCE UNDERSTANDINGS
a. The parties acknowledge and agree that the situation around COVID-19 is highly dynamic, evolving
rapidly, and subject to significant uncertainty. The Letter Contract is being executed on an expedited
timeline to meet an urgent and compelling Government need without the benefit of prior negotiation.
Thus, the parties will negotiate in good faith to ensure that the definitized contract reflects an
appropriate allocation of risk and responsibility and that it is consistent with the application and
preliminary work file submitted by the Contractor and subsequent documentation submitted during the
application review process and the discussions between the parties that have taken place between date
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of application submission through this Letter Contract issuance. Until the Performance Work Statement
(PWS) is finalized the Statement of Objective (SOO) will govern.
b. The parties anticipate that the definitive contract resulting from this Letter Contract will include a
negotiated firm fixed price not to exceed $33,421,500.The amount of funding provided for this Letter
Contract is stated in Article B.2 above, the contractor shall not incur costs in excess of this amount.
c. Commercial Item Status: The services provided by the Contractor under the Letter Contract and any
definitized contract constitute commercial item services, and the terms of any definitized contract will
reflect that understanding.
d. Performance Work Statement: The parties will negotiate a Performance Work Statement in the process
of contract definitization to fairly reflect the application and preliminary work file submitted by the
contractor and subsequent documentation submitted during the application review process and the
discussions between the parties that have taken place between application submission through letter
contract issuance.
e. HHS reserves the right to exercise priorities and allocations authority with respect to this Letter
Contract, to include rating this order in accordance with 45 CFR Part 101, Subpart A—Health Resources
Priorities and Allocations System.
f. The parties agree prior to negotiate further the terms of milestone payments to include in the
definitized contract. In the negotiation, the parties will consider terms addressing liquidation of
milestone payments.
g. Successful performance under this contract requires the Contractor obtain and maintain an Emergency
Use Authorization (EUA) from the Food and Drug Administration (FDA), EUA 201717 for NGS and
recently issued PCR EUA. The Contractor shall copy us on all FDA correspondence related to the project,
including email communications to and from the FDA. The FDA EUA services provided under this Letter
Contract constitute a commercial service to detect SARS-CoV-2.
h. Fair Pricing: The Rapid Acceleration of Diagnostics (RADx) application review process determined the
cost per test is competitive with the current market price. The Contractor must comply with applicable
federal law to ensure that prices to consumers are offered at fair market rate and at a rate consistent
with the objective to increase and improve testing in the United States.
i. Security and Privacy of Protected Health Information (PHI) processed under this contract: In the event
the Contractor meets the definition of either a Covered Entity or Business Associate under the Health
Insurance Portability and Accountability Act of 1996 (HIPAA), the Contractor shall comply with the
HIPAA regulatory standards set forth in the Code of Federal Regulations (CFR) 45 C.F.R. Part 160, Part
162, and Part 164. To the extent that the Contractor engages subcontractors or other Business
Associates to provide services under this Contract, and such Subcontractors or Business Associates will
receive or create PHI on behalf of the Contractor, the Contractor shall obtain satisfactory assurances
from its business associate that the business associate will appropriately safeguard the PHI. The
satisfactory assurances must be in writing, whether in the form of a contract or other agreement
between the Contractor and the business associate. In the event of a security or privacy breach
applicable to PHI processed under this contract, in addition to following the procedures set forth in 45
C.F.R. Part 164, the Contractor shall also immediately notify the NIH via the Contracting Officer (CO) and
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the Contracting Officer’s Representative (COR).
j. In accordance with the goals of the RADx program, the testing capabilities produced under this contract
are to be sold for utilization within the U.S. and its territories.
k. Sharing Data and Reports: The Contractor will be required to provide data and reports (e.g.,
manufacturing, supply chain, production rates), which NIH will use to evaluate completion or
achievement of milestones, progress toward deliverables, and compliance with the requirements of this
Letter Contract. NIH may use the data to coordinate with other U.S. Government Agencies to accelerate
development and deployment of innovative COVID-19 diagnostic tests, and ensure effective stewardship
of federal funds. Sharing data within the federal government enables NIH to discuss the project’s
challenges and progress with federal agencies offering scientific, manufacturing, and logistics expertise.
To ensure that innovations are available to the public as quickly as possible, NIH will leveragre
established partnerships with federal agencies, such as FDA, CDC, CMS, ASPR/BARDA, and the
Department of Defense, and partnerships with State agencies to propel technologies developed by RADx
into widespread use.
|. Contractor Facilities: The Contractor shall certify that they will maintain their Facility and Equipment in
satisfactory operating condition, as required to enable the Contractor to perform the deliverables and
achieve the milestones in accordance with the Statement of Objectives and all other applicable laws,
regulations, rules or orders. Routine repairs, preventive maintenance, and service contracts for the
Facility and Equipment shall be arranged by Contractor at no additional cost to the Government. The
laboratory must be CLIA certified and currently operating with appropriate equipment and trained staff.
m. The parties agree to address HHS Information Security and Privacy Requirements, as applicable, during
definitization of the contract.
n, Letter Contract Termination: In accordance with FAR 52.212-4 (|) Termination for the Government’s
Convenience. The Government reserves the right to terminate this contract, or any part hereof, for its
sole convenience. In the event of such termination, the Contractor shall immediately stop all work
hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work,
Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price
reflecting the percentage of the work performed prior to the notice of termination, plus reasonable
charges the Contractor can demonstrate to the satisfaction of the Government using its standard record
keeping system, have resulted from the termination. The Contractor shall not be required to comply
with the cost accounting standards or contract cost principles for this purpose. This paragraph does not
give the Government any right to audit the Contractor’s records. The Contractor shall not be paid for
any work performed or costs incurred which reasonably could have been avoided.
o. Letter Contract Termination: In accordance with FAR 52.212-4(m), the Government may terminate this
contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor
fails to comply with any contract terms and conditions, or fails to provide the Government, upon
request, with adequate assurances of future performance. In the event of termination for cause, the
Government shall not be liable to the Contractor for any amount for supplies or services not accepted,
and the Contractor shall be liable to the Government for any and all rights and remedies provided by
law. If it is determined that the Government improperly terminated this contract for default, such
termination shall be deemed a termination for convenience.
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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
ARTICLE C.1. STATEMENT OF OBJECTIVES
Independently and not as an agent of the Government, the Contractor shall furnish all the necessary
services, qualified personnel, material, equipment, and facilities, not otherwise provided by the
Government as needed to perform the Statement of Objectives, dated 07/27/2020, set forth in SECTION J-
List of Attachments, attached hereto and made a part of this Letter Contract. Work to be performed shall
be consistent with the application and preliminary work file submitted by the Contractor and subsequent
documentation submitted during the application review process and the discussions between the parties
that have taken place between date of application submission through Letter Contract award.
ARTICLE C.2. REPORTING REQUIREMENTS
All reports required herein shall be submitted in electronic format only. All electronic reports submitted shall be
compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents
for Section 508 compliance, including guidance and specific checklists, by application, can be found at:
http://www.hhs.gov/web/508/index.html under "Making Files Accessible."
Reporting requirements TBD.
SECTION D — PACKAGING, MARKING, AND SHIPPING
There are no additional instructions or specifications applicable to this Letter Contract other than the delivery
instructions contained herein.
SECTION E - INSPECTION AND ACCEPTANCE
a. The Contracting Officer or the duly authorized Contracting Officer’s Representative (COR) will perform
inspection and acceptance of deliverables to be performed and milestones to be achieved.
b. Inspection and acceptance will be performed as identified in the contract requirements.
SECTION F - DELIVERIES OR PERFORMANCE ARTICLE F.1. PERIOD OF PERFORMANCE
The period of performance of this contract is anticipated to be July 30, 2020 through July 29, 2021.
ARTICLE F.2. DELIVERIES
Satisfactory performance shall be deemed to occur upon performance of the work described in the Statement of
Objectives Article in SECTION C of this Letter Contract and upon notice and acceptance by the Contracting
Officer, or the duly authorized representative, in accordance with the stated deliverables schedule.
The deliverables or documentation shall be submitted to the Contracting Officer or designated Contracting
Officer Representative (COR).
SECTION G - CONTRACT ADMINISTRATION DATA
ARTICLE G.1. CONTRACTING OFFICER (CO)
Contract No. 75N92020C00006 Page 7
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The following Contracting Officer (CO) will represent the Government for the purpose of
this contract:
Name: Shirley Ruiz-Lundgren
Telephone: 301-827-7529
Email: shirley.ruiz-lundgren@nih.gov
The Contracting Officer is the only person with authority to act as agent of the Government
under this task order. Only the Contracting Officer has authority to:
1) direct or negotiate any changes in the Statement of Objectives or Performance Work Schedule;
2) modify or extend the period of performance;
3) change the deliverables or milestones schedule;
4) authorize reimbursement to the Contractor for any costs incurred during the performance of this
Letter Contract;
5) otherwise change any terms and conditions of this Letter Contract; or
6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in
Section K of this Letter Contract.
All correspondence (including invoices) that proposes or otherwise involves waivers, deviations, or
modifications to requirements shall be provided to the CO issuing this Letter Contract and the COR
supporting the CO,
ARTICLE G.2. CONTRACTING OFFICER'S REPRESENTATIVE (COR)
The following Contracting Officer's Representative (COR) is anticipated to represent the Government for
the purpose of this contract:
Olga Hartman, PhD
Telephone: 443-350-7696
Email: olga.hartman.civ@mail.mil
The COR is responsible for:
(1) monitoring the Contractor's technical progress, including the surveillance and assessment of
performance and recommending to the Contracting Officer changes in requirements;
(2) interpreting the Statement of Objectives or PWS and any other technical performance
requirements;
(3) performing technical evaluation as required;
(4) performing technical inspections and acceptances required by this Letter Contract; and
(5) assisting in the resolution of technical problems encountered during performance.
The Government may unilaterally change the COR designation.
ARTICLE G.3. PRIMARY PROGRAM MANAGER
The Primary Program Manager specified in this contract is considered to be essential to work
performance. At least 15 days prior to any changes to the individual listed below to other programs or
contracts (or as soon as reasonably possible, if an individual must be replaced, for example, as a result of
leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer.
Contract No. 75N92020C00006 Page 8
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James Lu, MD, PhD
Chief Scientific Officer
Primary Program Manager
Telephone:|
Emailf>@
ARTICLE G.4. INVOICE SUBMISSION
In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include
the following information on the face page of all task order payment requests:
a.
The Contract Title is: RADx ATP [75N92020C00006] [Helix OpCo, LLC] Reproducible clinical test system for
SARS-CoV-2 tests using amplicon sequencing
The Contract Line Items are defined within the Section 20. Schedule of Supplies/Services of the Standard
Form 1449.
Invoice Instructions are attached and made part of this Letter Contract. The Contractor shall follow the
attached instructions and submission procedures specified below to meet the requirements of a "proper
invoice" pursuant to FAR Subpart 32.9, Prompt Payment.
Payment requests shall be submitted to the offices identified below. Do not submit supporting
documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your payment request unless
specified elsewhere in the Letter Contract or requested by the Contracting Officer.
a. One copy of the invoice shall be submitted to the approving official at the following email
addresses:
NHLBI Branch B Central Mailbox (NHLBIContractsBranchB@mail.nih.gov)
NIH centralized invoice email box: invoicing@nih.gov
E-Mail: The Contractor shall submit an electronic copy of the payment request to the approving
official. The payment request shall be transmitted as an attachment via e-mail to the address listed
above in one of the following formats: MSWord, MS Excel, or Adobe Portable Document Format
(PDF). Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall
include the Contractor's name, contract number, and unique invoice number.
In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall
include the following information on the face page of all payment requests (invoices):
a. Name of the Office of Acquisitions. The Office of Acquisitions for this task order is NHLBI.
b. Central Point of Distribution. For the purpose of this Task Order, the Central Point of Distribution
is NHLBI Branch B Invoices.
c. Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall
identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number
that appears after the Contractor's name on the face page of the contract. [Note: A VIN is
assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to
include the VIN number.] If the Contractor has neither a TIN, DUNS, or VIN, contact the
Contracting Officer.
d. DUNS or DUNS+4 Number. The DUNS number must identify the Contractor's name and address
exactly as stated in the contract and as registered in the Central Contractor Registration (CCR)
database. If the Contractor does not have a valid DUNS number, it shall identify the Vendor
Identification Number (VIN) on the payment request. The VIN is the number that appears after
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the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts
awarded on or after June 4, 2007, and any existing contract modified to include the VIN
number.] \f the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.
e. Invoice Matching Option. This Letter Contract requires a two-way match.
Unique Invoice Number. Each payment request must be identified by a unique invoice number,
which can only be used one time regardless of the number of contracts or orders held by an
organization.
PRISM/NBS Line Item Number and associated PRISM/NBS Line Item Period of Performance (see
Section B — PRICES/OPTION).
d. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-6088.
SECTION H - ADDITONAL CONTRACT CLAUSES
ARTICLE H.1. SUBCONTRACTING PROVISIONS
a. Small Business Subcontracting Plan — The parties agree to address the requirements of this Article
1.
2.
during definitization of the contract, if applicable.
The Small Business Subcontracting Plan, dated is attached hereto and made a
part of this Letter Contract.
The failure of any Contractor or subcontractor to comply in good faith with FAR Clause 52.219-8,
entitled "Utilization of Small Business Concerns" incorporated in this Letter Contract and the
attached Subcontracting Plan, will be a material breach of such contract or subcontract and
subject to the remedies reserved to the Government under FAR Clause 52.219-16 entitled,
"Liquidated Damages-Subcontracting Plan."
b. Subcontracting Reports
The Contractor shall submit the following Subcontracting reports electronically via the "electronic
Subcontracting Reporting System (eSRS) at http://www.esrs.gov.
. Individual Subcontract Reports (ISR)
Regardless of the effective date of this contract, the Report shall be due on the following
dates for the entire life of this contract:
April 30th October 30th
Expiration Date of Contract
Summary Subcontract Report (SSR)
. Regardless of the effective date of this contract, the Summary Subcontract Report shall be
submitted annually on the following date for the entire life of this contract:
October 30th
For both the Individual and Summary Subcontract Reports, the Contracting Officer shall be included
as a contact for notification purposes at the following e-mail address:
Shirley Ruiz-Lundgren shirley.ruiz-lundgren@nih.gov
Contracting Officer
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ARTICLE H.2. CONFIDENTIALITY OF INFORMATION
a. Confidential information, as used in this article, means information or data of a personal
nature about an individual, or proprietary information or data submitted by or pertaining
to an institution or organization.
b. The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this
Letter Contract specific information and/or categories of information which the Government will
furnish to the Contractor or that the Contractor is expected to generate which is confidential.
Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such
confidential information from time to time during the performance of this Letter Contract.
Failure to agree will be settled pursuant to the "Disputes" clause.
c. Ifit is established elsewhere in this Letter Contract that information to be utilized under this
contract, or a portion thereof, is subject to the Privacy Act, the Contractor will follow the rules
and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing
regulations and policies, with respect to systems of records determined to be subject to the
Privacy Act.
d. Confidential information, as defined in paragraph (a) of this article, shall not be disclosed without
the prior written consent of the individual, institution, or organization.
e. Whenever the Contractor is uncertain with regard to the proper handling of material under the
contract, or if the material in question is subject to the Privacy Act or is confidential information
subject to the provisions of this article, the Contractor should obtain a written determination
from the Contracting Officer prior to any release, disclosure, dissemination, or publication.
f. Contracting Officer determinations will reflect the result of internal coordination with
appropriate program and legal officials.
g. The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping
provisions in other Federal, State or local laws.
ARTICLE H.3. PUBLICATION AND PUBLICITY
In addition to the requirements set forth in HHSAR Clause 352.227-70, Publications and Publicity
incorporated by reference in SECTION | of this contract, the Contractor shall acknowledge the
support of the National Institutes of Health whenever publicizing the work under this Letter
Contract in any media by including an acknowledgment substantially as follows:
"This project has been funded in whole or in part with Federal funds from the
Office of the Director, National Institutes of Health, Department of Health and
Human Services, under Contract No. 75N92020C00006.”
ARTICLE H.4. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE
Contract No. 75N92020C00006 Page 11
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Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in
NIH funded programs is encouraged to report such matters to the HHS Inspector General's Office
in writing or on the Inspector General's Hotline. The toll free number is 1-800-HHS-TIPS (1-800-
447-8477). All telephone calls will be handled confidentially. The website to file a complaint on-
line is: http://oig.hhs.gov/fraud/hotline/ and the mailing address is:
US Department of Health and Human Services Office of Inspector
General
ATTN: OIG HOTLINE OPERATIONS
P.O. Box 23489 Washington, D.C. 20026
PART Il - CONTRACT CLAUSES
SECTION I - CONTRACT CLAUSES
ARTICLE 1.1. ADDITIONAL CONTRACT CLAUSES
This Letter Contract incorporates the following clauses by reference, to the extent applicable, with the same
force and effect as if they were given in full text. - The parties agree to address the requirements of this Article
during definitization of the contract.
som
raposg
HHSAR Clause 352.227-70, Publications and Publicity
FAR Clause 52.212-3, Offeror Representations and Certifications - Commercial Items (Jun 2020)
FAR Clause 52.212-4 Contract Terms and Conditions - Commercial Items (Oct 2018)
FAR Clause 52.203-13, Contractor Code of Business Ethics and Conduct (October 2015)
FAR Clause 52.204-2, Security Requirements (August 1996).
1. Alternate | (April 1984) is not applicable to this contract.
2. Alternate II (April 1984) is not applicable to this contract.
FAR Clause 52.204-9, Personal Identity Verification of Contractor Personnel (January 2011).
FAR Clause 52.204-13, System for Award Management Maintenance
FAR Clause 52.204-18 Commercial and Government Entity Code Maintenance (July 2016)
FAR Clause 52.204-23 Prohibition on Contracting for Hardware, Software, and Services Developed or
Provided by Kaspersky Lab and Other Covered Entities
FAR Clause 52.209-10, Prohibition on Contracting With Inverted Domestic Corporations(November
2015).
FAR Clause 52.222-4, Contract Work Hours and Safety Standards - Overtime Compensation -General
(May 2014).
FAR Clause 52.222-29, Notification of Visa Denial (April 2015).
. FAR Clause 52.223-15, Energy Efficiency in Energy-Consuming Products (December 2007).
FAR Clause 52.224-1, Privacy Act Notification (April 1984).
FAR Clause 52.224-2, Privacy Act (April 1984).
FAR Clause 52.227-14, Rights in Data - General (May 2014).
FAR Clause 52.227-14, Rights in Data - General (May 2014) Alternate II (Dec 2007).
FAR Clause 52.232-40, Providing Accelerated Payments to Small Business Subcontractors
ARTICLE 1.2. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT
a.
FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES
Additional clauses other than those listed below which are based on the type of contract/Contractor
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shall be determined during negotiations. This Letter Contract incorporates the following clauses in full
text.
1.
3.
FAR 52.216-23 - EXECUTION AND COMMENCMENT OF WORK (APR 1984)
The Contractor shall indicate acceptance of this Letter Contract by signing One Copy of the contract
and returning them to the Contracting Officer not later than July 30, 2020, 12:00PM Eastern. Upon
acceptance by both parties, the Contractor shall proceed with performance of the work, including
purchase of necessary materials.
FAR 52.216-24 - LIMITATION OF GOVERNMENT LIABILITY (APR 1984)
(a) In performing this Letter Contract, the Contractor is not authorized to make expenditures orincur
obligations exceeding $13,022,500.00 dollars.
(b) The maximum amount for which the Government shall be liable if this Letter Contract is
terminated is $13,022,500.00 dollars.
FAR 52.216-25 - CONTRACT DEFINITIZATION (OCT 2010)
(a) A Firm Fixed Price (FFP) definitive contract is contemplated. The Contractor agrees to begin
promptly negotiating with the Contracting Officer the terms of a definitive contract that will include
(1) all clauses required by the Federal Acquisition Regulation (FAR) on the date of execution of the
letter contract, (2) all clauses required by law on the date of execution of the definitive contract,
and (3) any other mutually agreeable clauses, terms, and conditions. The Contractor agrees to
submit a Firm Fixed Price proposal, including data other than certified cost or pricing data, and
certified cost or pricing data, in accordance with FAR 15.408, Table 15-2, supporting its proposal.
(b) The schedule for definitizing this contract is as follows:
Definitization Schedule Date
Letter Contract Post Award Kick Off meeting 07/31/2020
Contractor Technical and Revised Price 08/07/2020
Proposal Submittal, to include subcontracting
plans, if applicable
Request Other than certified cost or pricing 08/14/2020
data
Project Officer’s Technical 08/17/2020
Questionnaire/Technical Evaluation & Review
Negotiations Start 08/18/2020
Definitization of Letter Contract 09/01/2020
(c) If agreement on a definitive contract to supersede this Letter Contract is not reached by the target
date in paragraph (b) of this section, or within any extension of it granted by the Contracting
Officer, the Contracting Officer may, with the approval of the head of the contracting activity,
determine a reasonable price or fee in accordance with subpart 15.4 and part 31 of the FAR,
subject to Contractor appeal as provided in the Disputes clause. In any event, the Contractor shall
proceed with completion of this Letter Contract, subject only to the Limitation of Government
Liability clause.
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(1)
(2)
After the Contracting Officer’s determination of price or fee, this Letter Contract shallbe
governed by-
(i) All clauses required by the FAR on the date of execution of this Letter Contract for
either fixed-price or cost-reimbursement contracts, as determined by the Contracting
Officer under this paragraph (c);
(ii) All clauses required by law as of the date of the Contracting Officer’s determination;
and
(iii) Any other clauses, terms, and conditions mutually agreed upon.
To the extent consistent with paragraph (c)(1) of this section, all clauses, terms, and
conditions included in this Letter Contract shall continue in effect, except those that by
their nature apply only to a Letter Contract.
4. FAR Clause 52.204-21, Basic Safeguarding of Covered Contractor Information Systems (Jun
2016)
(a) Definitions. As used in this clause—
Covered contractor information system means an information system that is owned or
operated by a contractor that processes, stores, or transmits Federal contract
information.
Federal contract information means information, not intended for public release, that is
provided by or generated for the Government under a contract to develop or deliver a
product or service to the Government, but not including information provided by the
Government to the public (such as on public websites) or simple transactional
information, such as necessary to process payments.
Information means any communication or representation of knowledge such as facts,
data, or opinions, in any medium or form, including textual, numerical, graphic,
cartographic, narrative, or audiovisual (Committee on National Security Systems
Instruction (CNSSI) 4009).
Information system means a discrete set of information resources organized for the
collection, processing, maintenance, use, sharing, dissemination, or disposition of
information (44 U.S.C. 3502).
Safeguarding means measures or controls that are prescribed to protect information
systems.
(b) Safeguarding requirements and procedures.
(1) The Contractor shall apply the following basic safeguarding requirements and
procedures to protect covered contractor information systems. Requirements and
procedures for basic safeguarding of covered contractor information systems shall
include, at a minimum, the following security controls:
(i) Limit information system access to authorized users, processes acting on behalf of
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authorized users, or devices (including other information systems).
(ii) Limit information system access to the types of transactions and functions that
authorized users are permitted to execute.
(iii) Verify and control/limit connections to and use of external information systems.
(iv) Control information posted or processed on publicly accessible information
systems.
v) Identify information system users, processes acting on behalf of users, or devices.
vi) Authenticate (or verify) the identities of those users, processes, or devices, as a
prerequisite to allowing access to organizational information systems.
vii) Sanitize or destroy information system media containing Federal Contract
Information before disposal or release for reuse.
viii) Limit physical access to organizational information systems, equipment, and the
respective operating environments to authorized individuals.
ix) Escort visitors and monitor visitor activity; maintain audit logs of physical access;
and control and manage physical access devices.
x) Monitor, control, and protect organizational communications (i.e., information
transmitted or received by organizational information systems) at the external
boundaries and key internal boundaries of the information systems.
xi) Implement subnetworks for publicly accessible system components that are
physically or logically separated from internal networks.
xii) Identify, report, and correct information and information system flaws in a timely
manner.
xiii) Provide protection from malicious code at appropriate locations within
organizational information systems.
xiv) Update malicious code protection mechanisms when new releases are available.
xv) Perform periodic scans of the information system and real-time scans of files from
external sources as files are downloaded, opened, or executed.
(2) Other requirements. This clause does not relieve the Contractor of any other specific
safeguarding requirements specified by Federal agencies and departments relating to
covered contractor information systems generally or other Federal safeguarding
requirements for controlled unclassified information (CUI) as established by Executive
Order 13556.
(c) Subcontracts. The Contractor shall include the substance of this clause, including this
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paragraph (c), in subcontracts under this contract (including subcontracts for the
acquisition of commercial items, other than commercially available off-the-shelf items), in
which the subcontractor may have Federal contract information residing in or transiting
through its information system.
(End of clause)
5. FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-
Commercial Items (Jul 2020)
(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses,
which are incorporated in this Letter Contract by reference, to implement provisions of law or
Executive orders applicable to acquisitions of commercial items:
(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or
Statements (JAN 2017) (section 743 of Division E, Title Vil, of the Consolidated and Further
Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in
subsequent appropriations acts (and as extended in continuing resolutions)).
(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or
Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L.
115-91).
(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video
Surveillance Services or Equipment. (Aug 2019) (Section 889(a)(1)(A) of Pub. L. 115-
232).
(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov
2015).
(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).
(6) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and
108-78 ( 19 U.S.C. 3805 note)).
(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting
Officer has indicated as being incorporated in this contract by reference to implement
provisions of law or Executive orders applicable to acquisitions of commercial items:
[Contracting Officer check as appropriate.] — The parties agree to address the requirements of
this Article during definization of the contract.
__ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (JUNE 2020),
with Alternate | (Oct 1995) ( 41U.S.C.4704 and 10 U.S.C. 2402).
___ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509)).
___ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment
Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the
American Recovery and Reinvestment Act of 2009.)
___ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN
2020) (Pub. L. 109-282) ( 31 U.S.C. 6101 note).
___ (5) [Reserved].
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___ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section
743 of Div. C).
___ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery
Contracts (OcT 2016) (Pub. L. 111-117, section 743 of Div. C).
___ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors
Debarred, Suspended, or Proposed for Debarment. (JUN 2020) (31 U.S.C. 6101 note).
___ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (OCT
2018) (41 U.S.C. 2313).
— (10)
— (11)
[Reserved].
(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (MAR
2020) (15 U.S.C. 657a).
— (12)
___ (ii) Alternate | (MAR 2020) of 52.219-3.
(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business
Concerns (Mar 2020) (if the offeror elects to waive the preference, it shall so indicate in its
off
fer) (15 U.S.C. 657a).
i) Alternate | (Mar 2020) of 52.219-4.
_ (13) [Reserved]
___ (14) (i) 52.219-6, Notice of Total Small Business Set-Aside (Mar 2020) of 52.219-
6 (15 U.S.C. 644).
i) Alternate | (MAR 2020) of 52.219-6 .
= (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (Mar 2020) (15 U.S.C. 644).
— (16
—(17
— (18
__ (ii) Alternate | (MAR 2020) of 52.219-7.
52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).
(i) 52.219-9, Small Business Subcontracting Plan (Jun 2020) (15 U.S.C. 637(d)(4)).
i) Alternate | (Nov 2016) of 52.219-9.
(iii) Alternate II (Nov 2016) of 52.219-9.
__ (iv)Alternate III (Jun 2020) of 52.219-9.
__ (v)AlterNate IV (JUN 2020) oF 52.219-9
(i) 52.219-13, Notice of Set-Aside of Orders (Mar 2020) (15 U.S.C. 644(r)).
___ (ii) Alternate | (Mar 2020) of 52.219-13.
___ (19) 52.219-14, Limitations on Subcontracting (Mar 2020) (15 U.S.C. 637(a)(14)).
___ (20) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan
19
(21
99) (15 U.S.C. 637(d)(4)(F)(i)).
52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Mar
2020) (15 U.S.C. 6574).
— (22
(i) 52.219-28, Post Award Small Business Program Rerepresentation (May
2020) (15 U.S.C. 632(a)(2)).
__ (ii) Alternate | (MAR 2020) of 52.219-28.
— (23
52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged
Women-Owned Small Business Concerns (Mar 2020) (15 U.S.C. 637(m)).
_ (24
52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small
Business Concerns Eligible Under the Women-Owned Small Business Program (Mar2020)
(15 U.S.C. 637(m)).
— (25
52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020)(15 U.S.C.
644(r)).
— (26
— (27
52.219-33, Nonmanufacturer Rule (Mar 2020) (15U.S.C. 637(a)(17)).
) 52.222-3, Convict Labor (Jun 2003) (E.0.11755).
___ (28) 52.222-19, Child Labor- Cooperation with Authorities and Remedies (Jan2020)
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(E.0.13126)
___ (29) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).
__ (30) (i) 52.222-26, Equal Opportunity (Sep 2016) (E.0.11246).
__ (ii) Alternate | (Fe8 1999) of 52.222-26.
__ (31) (i) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.
___ (ii) Alternate | (JuL 2014) of 52.222-35.
___ (32) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).
___ (ii) Alternate | (JuL 2014) of 52.222-36.
___ (33) 52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).
___ (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec
2010) (E.0. 13496).
___ (35) (i) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.O.
13627).
___ (ii) Alternate | (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).
___ (36) 52.222-54, Employment Eligibility Verification (Oct 2015). (Executive Order 12989). (Not
applicable to the acquisition of commercially available off-the-shelf items or certain other
types of commercial items as prescribed in 22.1803.)
___ (37) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA—Designated
Items (May 2008) ( 42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of
commercially available off-the-shelf items.)
__ (ii) Alternate | (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the
acquisition of commercially available off-the-shelf items.)
___ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential
Hydrofluorocarbons (Jun 2016) (E.0. 13693).
___ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air
Conditioners (Jun 2016) (E.0. 13693).
___ (40) (i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.0.s
13423 and 13514).
__ (ii) Alternate | (Oct 2015) of 52.223-13.
__ (41) (i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.0.s 13423 and
13514).
__ (ii) Alternate | (Jun2014) of 52.223-14.
___ (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (May
2020) (42 U.S.C. 8259b).
___ (43) (i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OcT
2015) (E.0.s 13423 and 13514).
___ (ii) Alternate | (JUN 2014) of 52.223-16.
__ (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun
2020) (E.0. 13513).
__ (45) 52.223-20, Aerosols (Jun 2016) (E.0. 13693).
__ (46) 52.223-21, Foams (Jun2016) (E.0. 13693).
__ (47) (i) 52.224-3 Privacy Training (JAN 2017) (5 U.S.C. 552 a).
__ (ii) Alternate | (JAN 2017) of 52.224-3.
___ (48) 52.225-1, Buy American-Supplies (May 2014) (41 U.S.C. chapter 83).
___ (49) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (May
2014) (41 U.S.C.chapter83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19
U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-
283, 110-138, 112-41, 112-42, and 112-43.
4212).
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__ (ii) Alternate | (May 2014) of 52.225-3.
__ (iii) Alternate Il (May 2014) of 52.225-3.
___ (iv) Alternate III (May 2014) of 52.225-3.
___ (50) 52.225-5, Trade Agreements (Oct 2019) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).
___ (51) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.0.’s, proclamations,
and statutes administered by the Office of Foreign Assets Control of the Department of the
Treasury).
___ (52) 52.225-26, Contractors Performing Private Security Functions Outside the United States
(Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal
Year 2008; 10 U.S.C. 2302Note).
___ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov2007) (42 U.S.C. 5150).
___ (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov2007)
(42 U.S.C. 5150).
___ (55) 52.229-12, Tax on Certain Foreign Procurements (JUN 2020).
___ (56) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb
2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).
___ (57) 52.232-30, Installment Payments for Commercial Items (Jan2017)
(41 U.S.C. 4505, 10 U.S.C. 2307(f)).
___ (58) 52.232-33, Payment by Electronic Funds Transfer-System for Award
Management (Oct2018) (31 U.S.C. 3332).
___ (59) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award
Management (Jul 2013) (31 U.S.C. 3332).
___ (60) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).
___ (61) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).
___ (62) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(13)).
___ (63) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (FEB
2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).
__ (ii) Alternate | (Apr 2003) of 52.247-64.
__ (iii) Alternate I! (Fe8 2006) of 52.247-64.
(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial
services, that the Contracting Officer has indicated as being incorporated in this contract by
reference to implement provisions of law or Executive orders applicable to acquisitions of
commercial items:
[Contracting Officer check as appropriate.)
___ (1) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter67).
___ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May
2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).
___ (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price
Adjustment (Multiple Year and Option Contracts) (Aug
2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).
___ (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price
Adjustment (May 2014) ( 29U.S.C.206 and 41 U.S.C. chapter 67).
___ (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to
Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May
2014) (41 U.S.C. chapter 67).
___ (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to
Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67).
___ (7) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).
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___ (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.0. 13706).
__ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020)
(42 U.S.C. 1792).
(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of
this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the
simplified acquisition threshold, as defined in FAR 2.101, on the date of award of this Letter
Contract, and does not contain the clause at 52.215-2, Audit and Records-Negotiation.
(1) The Comptroller General of the United States, or an authorized representative of the
Comptroller General, shall have access to and right to examine any of the Contractor’s
directly pertinent records involving transactions related to this Letter Contract.
(2) The Contractor shall make available at its offices at all reasonable times the records,
materials, and other evidence for examination, audit, or reproduction, until 3 years after
final payment under this Letter Contract or for any shorter period specified in FAR subpart
4.7, Contractor Records Retention, of the other clauses of this Letter Contract. If this Letter
Contract is completely or partially terminated, the records relating to the work terminated
shall be made available for 3 years after any resulting final termination settlement. Records
relating to appeals under the disputes clause or to litigation or the settlement of claims
arising under or relating to this Letter Contract shall be made available until such appeals,
litigation, or claims are finally resolved.
(3) As used in this clause, records include books, documents, accounting procedures and
practices, and other data, regardless of type and regardless of form. This does not require
the Contractor to create or maintain any record that the Contractor does not maintain in
the ordinary course of business or pursuant to a provision of law.
(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this
clause, the Contractor is not required to flow down any FAR clause, other than those in this
paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the
extent of the flow down shall be as required by the clause-
(i) 52.203-13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509).
(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or
Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further
Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in
subsequent appropriations acts (and as extended in continuing resolutions)).
(iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or
Provided by Kaspersky Lab and Other Covered Entities (JUL 2018) (Section 1634 of Pub. L.
115-91).
(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video
Surveillance Services or Equipment. (AUG 2019) (Section 889(a)(1)(A) of Pub. L. 115-232).
(v) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)), in
all subcontracts that offer further subcontracting opportunities. If the subcontract (except
subcontracts to small business concerns) exceeds the applicable threshold specified in
FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219-
8 in lower tier subcontracts that offer subcontracting opportunities.
(vi) 52.222-21, Prohibition of Segregated Facilities (APR 2015).
(vii) 52.222-26, Equal Opportunity (Sep 2015) (E.0.11246).
Contract No. 75N92020C00006 Page 20
DocuSign Envelope ID: F2830FDF-7A1B-4449-B6DD-E8572474DEE0
(viii) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).
(ix) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).
(x) 52.222-37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).
(xi) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC
2010) (E.0. 13496). Flow down required in accordance with paragraph (f) of FAR
clause 52.222-40.
(xii) 52.222-41, Service Contract Labor Standards (Aug2018) (41 U.S.C. chapter 67).
(xiii) (A) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.O
13627).
(B) Alternate | (Mar2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).
(xiv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to
Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements
(May2014) (41 U.S.C. chapter 67).
(xv) 52.222-53, Exemption from Application of the Service Contract Labor Standards to
Contracts for Certain Services-Requirements (MAY2014) (41 U.S.C. chapter 67).
(xvi) 52.222-54, Employment Eligibility Verification (OcT 2015) (E.0. 12989).
(xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).
(xviii) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).
(xix) (A) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).
(B) Alternate | (Jan 2017) of 52.224-3.
(xx) 52.225-26, Contractors Performing Private Security Functions Outside the United
States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for
Fiscal Year 2008; 10 U.S.C. 2302 Note).
(xxi) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun
2020) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR
clause 52.226-6.
(xxii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb
2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance
with paragraph (d) of FAR clause 52.247-64.
(2) While not required, the Contractor may include in its subcontracts for commercial items a
minimal number of additional clauses necessary to satisfy its contractual obligations.
(End of clause)
PART Ill - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS
SECTION J LIST OF ATTACHMENTS
1. Statement of Objectives
2. Helix Contract Deliverables
Contract No. 75N92020C00006 Page 21
SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS
OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30
7” REQUISITION NUMBER PAGE OF
5766140 1 22
2 CONTRACT NO, [3 AWAROY Js. ORDER NUMBER 5. SOLICITATION NUMBER Is. SOLICITATION
75N92020C00007 EFFECTIVE DATE Issue DATE
7. FOR SOLICITATION fa. NAME jp TELEPHONE NUMBER (No colectcall) JB. OFFER DUE DATE/LOCAL TIME
INFORMATION CALL: SHIRLEY RUIZ-LUNDGREN +1 301 827 7529
‘9, ISSUED BY cove [NHLBI 10. THISACQUISTIONIS -X—_UUNRESTRICTEDOR SETASIDE: % FOR:
: . WOMEN-OWNED SMALL BUSINESS
National Institutes of Health Sw UCN (WOSB) ELIGIBLE UNDER THE WOMEN-OWNED
National Heart, Lung, and Blood HUBZONE SMALL SMAII RIISINESS PROGRAM waics:621511
Institute BUSINESS eDwose
ay SSERVICE-DISABLED 8A)
Bethesda, MD 20892-7511 pratilireony swe stanoaro: $35.0
‘SMALL BUSINESS
Wi, DELIVERY FOR FOB DESTINA- [12 DISCOUNT TERMS 3b, RATING
TION UNLESS BLOCK IS 19a, THIS CONTRACTISA
MARKED RATED ORDER UNDER
Ta METHOD OF SOLIGTATION
X! SEE SCHEDULE PAS (15 CFR 700) ea is nee
75. DELVERTO CODE 16, ADMINISTERED BY CODE NHLBI
Multiple Destinations National Institutes of Health
National Heart, Lung, and Blood
Institute
Bethesda, MD 20892-7511
Wa, CONTRACTOR! ‘CODE FACILITY a, PAYMENT WILL BE MADE BY CODE
NTA am 2115 E JEFFERSOD
GINKGO BIOWORKS, INC.:1224133
27 DRYDOCK AVENUE
FLOOR 8
BOSTON MA 022102413
‘TELEPHONE NO,
2115 E Jefferson St
MSC 8500 Suite 4B 432
Bethesda, MD 20892-8500
7b, CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER
'18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW
IS CHECKED ‘SEE ADDENDUM
19, 20. 21 22. 23. 24,
ITEM NO, ‘SCHEDULE OF SUPPLIESISERVICES QUANTITY |UNIT UNIT PRICE AMOUNT
Itechnology Platform (RADx-ATP)
ICov-2.
(NIH)
(Use Reverse and/or Attach Additional Sheets as Necessary)
25. ACCOUNTING AND APPROPRIATION DATA
Rapid Acceleration of Diagnostics Advanced
Project #6381: High-Throughput Next Generation
Sequencing based Molecular Diagnostic for SARS-
This Letter Contract forms a preliminary
lunderstanding between Ginkgo Bioworks Inc.
(Ginkgo) and the National Institutes of Health
and is issued as a result of the Rapid
lacceleration of Diagnostics Advanced Technology
Platforms (RADx-ATP) program to increase the
testing capacity of high throughput labs by
TOTAL AWARD AMOUNT (For Govt. Use Only)
$6,574,473.60
1 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 2.2125 ARE ATTACHED. ADDENDA ARE (_] ARE NOT ATTACHED.
% 27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA X ARE ARE NOT ATTACHED,
X28, CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN 1 29. AWARD OF CONTRACT: OFFER
COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER
ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL,
SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.
DATED YOUR OFFER ON SOLICITATION (BLOCK 5),
INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH
HEREIN. IS ACCEPTED AS TO ITEMS:
‘30a, SIGNATURE OF OF FERORIGONTRAGTOR
“31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)
Shirley Ruiz-lundgren Disitally signed by Shirley Ruiz-
Jundgren -S
-S Date: 2020.07.30 121
42 -04°00'
[30c. DATE SIGNED
07 / 30/2020
30b. NAME AND TITLE OF SIGNER (Type or print)
Reshma Shetty, President, COO
[31b. NAME OF CONTRACTING OFFICER (Type or print) [31c. DATE SIGNED
ISHIRLEY RUIZ-LUNDGREN
AUTHORIZED FOR LOCAL REPRODUCTION.
PREVIOUS EDITION IS NOT USABLE
‘STANDARD FORM 1449 (REV. 2/2012)
Prescribed by GSA - FAR (48 CFR) 53.212
19, 20. 2 22 23. 24
ITEM NO, ‘SCHEDULE OF SUPPLIESISERVICES. ‘Quantity | UNIT UNIT PRICE AMOUNT
scaling up late stage testing platforms for
detecting SARS-CoV-2, the virus that causes
COVID-19. This Letter Contract is an
Undefinitized Contract Action that will be
definitized in accordance with the schedule
contained herein.
Period of Performance: 07/30/2020 to 07/29/2021
1 Task 1: Program Risk Management Fe
Obligated Amount
Delivery To: Rm 126
Product/Service Code: Q301
Product/Service Description: MEDICAL- LABORATORY
TESTING
Delivery: 07/29/2021
anount:B—]
2 Phase 1: Emergency Use Authorized Lab &
Operational Capacity of 320-960 tests/day
Obligated Amount:
Delivery To: Rm 126
Product/Service Code: 301
Product/Service Description: MEDICAL- LABORATORY
TESTING
Delivery: 08/12/2020
meso:
Continued ...
32a, QUANTITY IN COLUMN 21 HAS BEEN
RECEIVED INSPECTED ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:
32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE 320. DATE 32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE
32e, MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE
32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE,
33. SHIP NUMBER [35. AMOUNT VERIFIED 36. PAYMENT
CORRECT FOR
139. SIR VOUCHER NUMBER
41a. | CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT
41b, SIGNATURE AND TITLE OF CERTIFYING OFFICER 4c. DATE
37. CHECK NUMBER
COMPLETE PARTIAL
PARTIAL FINAL
38, SIR ACCOUNT NUMBER 140. PAID BY
42a. RECEIVED BY (Print)
42b. RECEIVED AT (Location)
|42c. DATE REC'D (YY/MM/DD) 42d, TOTAL CONTAINERS
‘STANDARD FORM 1449 (REV. 2/2012) BACK
EFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE
CONTINUATION SHEET 15N'92020C00007
3
NAME OF OFFEROR OR CONTRACTOR
GINKGO BIOWORKS, INC. :1224133
ITEM No. SUPPLIESISERVICES QUANTITY UNIT UNIT PRICE AMOUNT
(A) (B) (Cc) (D) (E) (F)
3 Phase 2: Emergency Use Authorized Lab & fon)
Operational Capacity of 960-1440 tests/day
Delivery To: Rm 126
Product/Service Code: Q301
Product/Service Description: MEDICAL- LABORATORY
TESTING
Deliver 08/31/2020
Amount pa
NSN 7540-01-152-8067 ‘OPTIONAL FORM 336 (4-66)
‘Sponsored by GSA
FAR (48 CFR) 53.110
PART | —- THE SCHEDULE
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
ARTICLE B.1. BRIEF DESCRIPTION OF SERVICES
This Letter Contract forms a preliminary understanding between Ginkgo Bioworks, Inc. (Ginkgo) and the
National Institutes of Health (NIH) and is issued as a result of the Rapid Acceleration of Diagnostics Advanced
Technology Platforms (RADx-ATP) program to increase the testing capacity of high throughput labs by scaling up
late stage testing platforms for detecting SARS-CoV-2, the virus that causes COVID-19. Issuance of this Letter
Contract authorizes the Contractor to immediately begin the activities necessary to perform the requirements as
identified in the Statement of Objectives covering the full range of activities needed to increase capacity and
optimize throughput necessary to distribute a viable product to the public.
The scope of work executed under this contract, includes completing the validation, approval, and production
processes in order to deliver a viable product in a scaled up capacity to the U.S. public. The Ginkgo technology to
support this effort is to use Next Generation Sequencing (NGS) technology ——s—i(‘i‘CS™S*‘*@d
This Letter Contract has been issued based on the submissions by the contractor under the RADx-ATP program,
which includes the application and preliminary work file and subsequent documentation submitted during the
review process. The Contractor’s inability to meet the requirements as defined within this Letter Contract and
proposed within the application process may result in the termination of the Letter Contract in accordance with
the termination clauses contained herein.
ARTICLE B.2. PRICES
a. The total Firm Fixed Price (FFP) amount for this Letter Contract is $6,574,473.60.
b. Pricing Schedule
Milestone _| Date l Description Price
(oa) bya)
ARTICLE B.3. ADVANCE UNDERSTANDINGS
a. The parties acknowledge and agree that the situation around COVID-19 is highly dynamic, evolving
rapidly, and subject to significant uncertainty. The Letter Contract is being executed on an expedited
timeline to meet an urgent and compelling government need without the benefit of prior negotiation.
Thus, the parties will negotiate in good faith to ensure that the definitized contract reflects an
appropriate allocation of risk and responsibility and that it is consistent with the application and
Contract No. 75N92020C00007 Page 4
preliminary work file submitted by the contractor and subsequent documentation submitted during the
application review process and the discussions between the parties that have taken place between date
of application submission through Letter Contract issuance. Until the Performance Work Statement
(PWS) is finalized the Statement of Objective (SOO) will govern.
b. The parties anticipate that the definitive contract resulting from this Letter Contract will include a
negotiated firm fixed price not to exceed $40,473,831.60. The amount of funding provided for
this Letter Contract is stated in Article B.2 above, the contractor shall not incur costs in excess of this
amount.
c. Commercial Item Status: The services provided by the Contractor under the Letter Contract and any
definitized contract constitute commercial item services, and the terms of any definitized contract will
reflect that understanding.
d. Performance Work Statement: The parties will negotiate the Performance Work Statement in the
process of contract definitization to fairly reflect the application and preliminary work file submitted by
the contractor and subsequent documentation submitted during the application review process and the
discussions between the parties that have taken place between application submission through letter
contract issuance.
e. HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to
include rating this order in accordance with 45 CFR Part 101, Subpart A—Health Resources Priorities and
Allocations System.
f. The parties agree prior to negotiate further the terms of milestone payments to include in the
definitized contract. In the negotiation, the parties will consider terms addressing liquidation of
milestone payments.
yay
h. Fair Pricing: The Rapid Acceleration of Diagnostics (RADx) application review process determined the
cost per test is competitive with the current market price. The Contractor must comply with applicable
federal law to ensure that prices to consumers are offered at fair market rate and at a rate consistent
with the objective to increase and improve testing in the United States.
i. Security and Privacy of Protected Health Information (PHI) processed under this contract: In the event
the Contractor meets the definition of either a Covered Entity or Business Associate under the Health
Insurance Portability and Accountability Act of 1996 (HIPAA). The contractor shall therefore comply
with the HIPAA regulatory standards set forth in the Code of Federal Regulations (CFR) 45 C.F.R. Part
160, Part 162, and Part 164. To the extent that the Contractor engages subcontractors or other Business
Associates to provide services under this Contract, and such Subcontractors or Business Associates will
receive or create protected health information (PHI) on behalf of the contractor, the contractor shall
obtain satisfactory assurances from its business associate that the business associate will appropriately
safeguard the protected health information. The satisfactory assurances must be in writing, whether in
the form of a contract or other agreement between the Contractor and the business associate. In the
Contract No. 75N92020C00007 Page 5
event of a suspected or known security or privacy breach, in addition to following the procedures set
forth in 45 C.F.R. Part 164, the contractor shall also immediately notify the NIH via the Contracting
Officer (CO)and the Contracting Officer’s Representative (COR).
j. In accordance with the goals of the RADx program, the testing capabilities produced under this contract
are to be for utilization within the U.S. and its territories.
k. Sharing Data and Reports: The Contractor will be required to provide data and reports (e.g.,
manufacturing, supply chain, production rates), which NIH will use to evaluate completion or
achievement of milestones, progress toward deliverables, and compliance with the requirements of this
Letter Contract. NIH may use the data to coordinate with other U.S. Government Agencies to accelerate
development and deployment of innovative COVID-19 diagnostic tests, and ensure effective stewardship
of federal funds. Sharing data within the federal government enables NIH to discuss the project’s
challenges and progress with federal agencies offering scientific, manufacturing, and logistics expertise.
To ensure that innovations are available to the public as quickly as possible, NIH will leverage
established partnerships with federal agencies, such as FDA, CDC, CMS, ASPR/BARDA, and the
Department of Defense, and partnerships with State agencies to propel technologies developed by RADx
into widespread use.
|. Contractor Facilities: The contractor shall certify that they will maintain their Facility and Equipment in
satisfactory operating condition, as required to enable the contractor to perform the deliverables and
achieve the milestones in accordance with the Statement of Objectives and all other applicable laws,
regulations, rules or orders. Routine repairs, preventive maintenance, and service contracts for the
Facility and Equipment shall be arranged by contractor at no additional cost to the Government.
m. The parties agree to address HHS Information Security and Privacy Requirements, as applicable, during
definitization of the contract.
n. Letter Contract Termination: In accordance with FAR 52.212-4 (|) Termination for the Government's
convenience. The Government reserves the right to terminate this contract, or any part hereof, for its
sole convenience. In the event of such termination, the Contractor shall immediately stop all work
hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work.
Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price
reflecting the percentage of the work performed prior to the notice of termination, plus reasonable
charges the Contractor can demonstrate to the satisfaction of the Government using its standard record
keeping system, have resulted from the termination. The Contractor shall not be required to comply
with the cost accounting standards or contract cost principles for this purpose. This paragraph does not
give the Government any right to audit the Contractor’s records. The Contractor shall not be paid for
any work performed or costs incurred which reasonably could have been avoided.
o. Letter Contract Termination: In accordance with FAR 52.212-4(m), the Government may terminate this
contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor
fails to comply with any contract terms and conditions, or fails to provide the Government, upon
request, with adequate assurances of future performance. In the event of termination for cause, the
Government shall not be liable to the Contractor for any amount for supplies or services not accepted,
and the Contractor shall be liable to the Government for any and all rights and remedies provided by
law. If it is determined that the Government improperly terminated this contract for default, such
termination shall be deemed a termination for convenience.
Contract No. 75N92020C00007 Page 6
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
ARTICLE C.1. STATEMENT OF OBJECTIVES
Independently and not as an agent of the Government, the Contractor shall furnish all the necessary
services, qualified personnel, material, equipment, and facilities, not otherwise provided by the
Government as needed to perform the Statement of Objectives, dated July 27, 2020, set forth in SECTION
J-List of Attachments, attached hereto and made a part of this Leter Contract. Work to be performed shall
be consistent with the application and preliminary work file submitted by the Contractor and subsequent
documentation submitted during the application review process and the discussions between the parties
that have taken place between date of application submission through Letter Contractaward.
ARTICLE C.2. REPORTING REQUIREMENTS
All reports required herein shall be submitted in electronic format only. All electronic reports submitted shall be
compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents
for Section 508 compliance, including guidance and specific checklists, by application, can be found at:
http://www.hhs.gov/web/508/index.html under "Making Files Accessible."
Reporting requirements TBD.
SECTION D — PACKAGING, MARKING, AND SHIPPING
There are no additional instructions or specifications applicable to this contract other than the delivery
instructions contained herein.
SECTION E - INSPECTION AND ACCEPTANCE
a. The Contracting Officer or the duly authorized Contracting Officer’s Representative (COR) will perform
inspection and acceptance of deliverables to be performed and the milestones to be achieved.
b. Inspection and acceptance will be performed as identified in the contract requirements.
SECTION F - DELIVERIES OR PERFORMANCE ARTICLE F.1. PERIOD OF PERFORMANCE
The period of performance of this contract is anticipated to be July 30, 2020 through July 29, 2021.
ARTICLE F.2. DELIVERIES
Satisfactory performance shall be deemed to occur upon performance of the work described in the Statement of
Objectives Article in SECTION C of this Letter Contract and upon notice and acceptance by the Contracting
Officer, or the duly authorized representative, in accordance with the stated deliverables schedule.
The deliverables or documentation shall be submitted to the Contracting Officer or designated Contracting
Officer Representative (COR).
SECTION G - CONTRACT ADMINISTRATION DATA
Contract No. 75N92020C00007 Page 7
ARTICLE G.1. CONTRACTING OFFICER (CO)
The following Contracting Officer (CO) will represent the Government for the purpose of
this contract:
Name: Shirley Ruiz-Lundgren
Telephone: 301-827-7529
Email: shirley.ruiz-lundgren@nih.gov
The Contracting Officer is the only person with authority to act as agent of the Government
under this task order. Only the Contracting Officer has authority to:
1) direct or negotiate any changes in the Satement of Objectives or Performance Work Statement;
2) modify or extend the period of performance;
3) change the deliverables or milestones schedule;
4) authorize reimbursement to the Contractor for any costs incurred during the performance of this
Letter Contract;
5) otherwise change any terms and conditions of this Letter Contract; or
6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in
Section K of this Letter Contract.
All correspondence (including invoices) that proposes or otherwise involves waivers, deviations, or modifications
to requirement shall be provided to the CO issuing this Letter Contract and the COR supporting the CO.
ARTICLE G.2. CONTRACTING OFFICER'S REPRESENTATIVE (COR)
The following Contracting Officer's Representative (COR) is anticipated to represent the Government for
the purpose of this contract:
Olga Hartman, PhD
Telephone: 443-350-7696
Email: olga.hartman.civ@mail.mil
The COR is responsible for:
(1) monitoring the Contractor's technical progress, including the surveillance and assessment of
performance and recommending to the Contracting Officer changes in requirements;
(2) interpreting the Statement of Objectives and any other technical performance requirements;
(3) performing technical evaluation as required;
(4) performing technical inspections and acceptances required by this Letter Contract; and
(5) assisting in the resolution of technical problems encountered during performance.
The Government may unilaterally change the COR designation.
ARTICLE G.3. PRIMARY PROGRAM MANAGER
The Primary Program Manager specified in this task order is considered to be essential to work
performance. At least 30 days prior to any changes to the individual listed below to other programs or task
orders (or as soon as reasonably possible, if an individual must be replaced, for example, as a result of
leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit
comprehensive justification for the change request (including proposed substitutions for primary program
manager) to permit evaluation by the Government of the impact on performance under this task order.
Contract No. 75N92020C00007 Page 8
The Contractor shall not replace any primary program manager without the written consent of the
Contracting Officer. The Government may modify the task order to add or delete primary program
manager at the request of the contractor or Government. In no case shall the individual’s effort exceed
100% across all task orders.
Reshma Shetty
Co-Founder and Chief Operating Officer
Primary Program Manager
Telephone}?
Email foe
ARTICLE G.4. INVOICE SUBMISSION
In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include
the following information on the face page of all task order payment requests:
a. The Contract Title is: RADx ATP [75N92020C00007] [Ginkgo Bioworks, Inc] High-Throughput Next
Generation Sequencing based Molecular Diagnostic for SARS-CoV-2
b. The Contract Line Items are defined within the Section 20. Schedule of Supplies/Services of the Standard
Form 1449.
c. Invoice Instructions are attached and made part of this Letter Contract. The Contractor shall follow the
attached instructions and submission procedures specified below to meet the requirements of a "proper
invoice" pursuant to FAR Subpart 32.9, Prompt Payment.
1. Payment requests shall be submitted to the offices identified below. Do not submit supporting
documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your payment request unless
specified elsewhere in this Letter Contract or requested by the Contracting Officer.
a. One copy of the invoice shall be submitted to the approving official at the following email
addresses:
NHLBI Branch B Central Mailbox (NHLBIContractsBranchB@mail.nih.gov)
NIH centralized invoice email box: invoicing@nih.gov
2. E-Mail: The Contractor shall submit an electronic copy of the payment request to the approving
official. The payment request shall be transmitted as an attachment via e-mail to the address listed
above in one of the following formats: MSWord, MS Excel, or Adobe Portable Document Format
(PDF). Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall
include the Contractor's name, contract number, and unique invoice number.
3. In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall
include the following information on the face page of all payment requests (invoices):
a. Name of the Office of Acquisitions. The Office of Acquisitions for this task order is NHLBI.
b. Central Point of Distribution. For the purpose of this Task Order, the Central Point of Distribution
is NHLBI Branch B Invoices.
c. Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall
identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number
that appears after the Contractor's name on the face page of the contract. [Note: A VIN is
assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to
Contract No. 75N92020C00007 Page 9
include the VIN number.] \f the Contractor has neither a TIN, DUNS, or VIN, contact the
Contracting Officer.
d. DUNS or DUNS+4 Number. The DUNS number must identify the Contractor's name and address
exactly as stated in the contract and as registered in the Central Contractor Registration (CCR)
database. If the Contractor does not have a valid DUNS number, it shall identify the Vendor
Identification Number (VIN) on the payment request. The VIN is the number that appears after
the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts
awarded on or after June 4, 2007, and any existing contract modified to include the VIN
number.] \|f the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.
e. Invoice Matching Option. This Letter Contract requires a two-way match.
f. Unique Invoice Number. Each payment request must be identified by a unique invoice number,
which can only be used one time regardless of the number of contracts or orders held by an
organization.
g. PRISM/NBS Line Item Number and associated PRISM/NBS Line Item Period of Performance (see
Section B — PRICES/OPTION).
d. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-6088.
SECTION H - ADDITIONAL CONTRACT CLAUSES
ARTICLE H.1. PRIVACY ACT, HHSAR 352.224-70 (December 2015)
This contract requires the Contractor to perform one or more of the following: (a) Design; (b) develop;
or (c) operate a Federal agency system of records to accomplish an agency function in accordance with
the Privacy Act of 1974 (Act) (5 U.S.C. 552a(m)(1)) and applicable agency regulations.
The term "system of records" means a group of any records under the control of any agency from
which information is retrieved by the name of the individual or by some identifying number, symbol,
or other identifying particular assigned to the individual. Violations of the Act by the Contractor and/or
its employees may result in the imposition of criminal penalties (5 U.S.C. 552a(i)).
The Contractor shall ensure that each of its employees knows the prescribed rules of conduct in CFR
45 part 5b and that each employee is aware that he/she is subject to criminal penalties for violation
of the Act to the same extent as Department of Health and Human Services employees. These
provisions also apply to all subcontracts the Contractor awards under this contract which require the
design, development or operation of the designated system(s) of records [5 U.S.C. 552a(m)(1)]. The
contract work statement:
(a) identifies the system(s) of records and the design, development, or operation work the
Contractor is to perform; and
(b) specifies the disposition to be made of such records upon completion of contract performance.
ARTICLE H.2. SUBCONTRACTING PROVISIONS
a. Small Business Subcontracting Plan — The parties agree to address the requirements of this Article
Contract No. 75N92020C00007 Page 10
during definitization of the contract.
1, PO
2. (Oa
b. Subcontracting Reports
The Contractor shall submit the following Subcontracting reports electronically via the "electronic
Subcontracting Reporting System (eSRS) at http://www.esrs.gov.
1. Individual Subcontract Reports (ISR)
Regardless of the effective date of this contract, the Report shall be due on the following
dates for the entire life of this contract:
[b)(4)
Summary Subcontract Report (SSR)
2. Regardless of the effective date of this contract, the Summary Subcontract Report shall be
submitted annually on the following date for the entire life of this contract:
For both the Individual and Summary Subcontract Reports, the Contracting Officer shall be included
as a contact for notification purposes at the following e-mail address:
Shirley Ruiz-Lundgren shirley.ruiz-lundgren@nih.gov
Contracting Officer
ARTICLE H.3. CONFIDENTIALITY OF INFORMATION
a. Confidential information, as used in this article, means information or data of a personal
nature about an individual, or proprietary information or data submitted by or pertaining
to an institution or organization.
b. The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this
Letter Contract specific information and/or categories of information which the Government will
furnish to the Contractor or that the Contractor is expected to generate which is confidential.
Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such
confidential information from time to time during the performance of the Letter Contract.
Failure to agree will be settled pursuant to the "Disputes" clause.
c. If it is established elsewhere in this Letter Contract that information to be utilized under this
contract, or a portion thereof, is subject to the Privacy Act, the Contractor will follow the rules
and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing
Contract No. 75N92020C00007 Page 11
regulations and policies, with respect to systems of records determined to be subject to the
Privacy Act.
d. Confidential information, as defined in paragraph (a) of this article, shall not be disclosed without
the prior written consent of the individual, institution, or organization.
e. Whenever the Contractor is uncertain with regard to the proper handling of material under the
contract, or if the material in question is subject to the Privacy Act or is confidential information
subject to the provisions of this article, the Contractor should obtain a written determination
from the Contracting Officer prior to any release, disclosure, dissemination, or publication.
f. Contracting Officer determinations will reflect the result of internal coordination with
appropriate program and legal officials.
g. The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping
provisions in other Federal, State or local laws.
ARTICLE H.4. PUBLICATION AND PUBLICITY
In addition to the requirements set forth in HHSAR Clause 352.227-70, Publications and Publicity
incorporated by reference in SECTION | of this contract, the Contractor shall acknowledge the
support of the National Institutes of Health whenever publicizing the work under this Letter
Contract in any media by including an acknowledgment substantially as follows:
"This project has been funded in whole or in part with Federal funds from the Office of the
Director, National Institutes of Health, Department of Health and Human Services, under
Contract No. 75N92020C00007.
ARTICLE H.5. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE
Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in
NIH funded programs is encouraged to report such matters to the HHS Inspector General's Office
in writing or on the Inspector General's Hotline. The toll free number is 1-800-HHS-TIPS (1-800-
447-8477). All telephone calls will be handled confidentially. The website to file a complaint on-
line is: http://oig.hhs.gov/fraud/hotline/ and the mailing address is:
US Department of Health and Human Services Office of Inspector
General
ATTN: OIG HOTLINE OPERATIONS
P.O. Box 23489 Washington, D.C. 20026
PART II - CONTRACT CLAUSES SECTION | - CONTRACT CLAUSES
ARTICLE 1.1. ADDITIONAL CONTRACT CLAUSES
This contract incorporates the following clauses by reference, (unless otherwise noted), with the same force and
effect as if they were given in full text. — The parties agree to address the requirements of this Article during
Contract No. 75N92020C00007 Page 12
definitization of the contract.
a.
nao
rapos3g >
HHSAR Clause 352.227-70, Publications and Publicity
FAR Clause 52.212-3, Offeror Representations and Certifications - Commercial Items (Jun 2020)
FAR Clause 52.212-4 Contract Terms and Conditions — Commercial Items (Oct 2018)
FAR Clause 52.203-13, Contractor Code of Business Ethics and Conduct (October 2015)
FAR Clause 52.204-2, Security Requirements (August 1996).
1. Alternate | (April 1984) is not applicable to this contract.
2. Alternate II (April 1984) is not applicable to this contract.
FAR Clause 52.204-9, Personal Identity Verification of Contractor Personnel (January 2011).
FAR Clause 52.204-13, System for Award Management Maintenance
FAR Clause 52.204-18 Commercial and Government Entity Code Maintenance (July 2016)
FAR Clause 52.204-23 Prohibition on Contracting for Hardware, Software, and Services Developed or
Provided by Kaspersky Lab and Other Covered Entities
FAR Clause 52.209-10, Prohibition on Contracting With Inverted Domestic Corporations(November
2015).
FAR Clause 52.222-4, Contract Work Hours and Safety Standards - Overtime Compensation -General
(May 2014).
FAR Clause 52.222-29, Notification of Visa Denial (April 2015).
. FAR Clause 52.223-15, Energy Efficiency in Energy-Consuming Products (December 2007).
FAR Clause 52.224-1, Privacy Act Notification (April 1984).
FAR Clause 52.224-2, Privacy Act (April 1984).
FAR Clause 52.227-14, Rights in Data - General (May 2014).
FAR Clause 52.227-14, Rights in Data - General (May 2014) Alternate II (Dec 2007).
FAR Clause 52.232-40, Providing Accelerated Payments to Small Business Subcontractors
ARTICLE 1.2. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT
FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES
Additional clauses other than those listed below which are based on the type of contract/Contractor
shall be determined during negotiations. This contract incorporates the following clauses in full text.
1. FAR 52.216-23 - EXECUTION AND COMMENCMENT OF WORK (APR 1984)
The Contractor shall indicate acceptance of this letter contract by signing One Copy of this Letter
Contract and returning them to the Contracting Officer not later than July 30, 2020, 9:00AM EST.
Upon acceptance by both parties, the Contractor shall proceed with performance of the work,
including purchase of necessary materials.
2. FAR 52.216-24 - LIMITATION OF GOVERNMENT LIABILITY (APR 1984)
(a) In performing this Letter Contract, the Contractor is not authorized to make expenditures orincur
obligations exceeding $6,574,473.60 dollars.
(b) The maximum amount for which the Government shall be liable if this Letter Contract is
terminated is $6,574,473.60 dollars.
3. FAR 52.216-25 - CONTRACT DEFINITIZATION (OCT 2010)
(a) A Firm Fixed Price (FFP) definitive contract is contemplated. The Contractor agrees to begin promptly
Contract No. 75N92020C00007 Page 13
negotiating with the Contracting Officer the terms of a definitive contract that will include (1) all clauses
required by the Federal Acquisition Regulation (FAR) on the date of execution of the letter contract, (2) all
clauses required by law on the date of execution of the definitive contract, and (3) any other mutually
agreeable clauses, terms, and conditions. The Contractor agrees to submit a Firm Fixed Price proposal,
including data other than certified cost or pricing data, and certified cost or pricing data, in accordance with
FAR 15.408, Table 15-2, supporting its proposal.
(b) The schedule for definitizing this contract is as follows:
Definitization Schedule | Date
bya)
(c) If agreement on a definitive contract to supersede this letter contract is not reached by the target
date in paragraph (b) of this section, or within any extension of it granted by the Contracting
Officer, the Contracting Officer may, with the approval of the head of the contracting activity,
determine a reasonable price or fee in accordance with subpart 15.4 and part 31 of the FAR,
subject to Contractor appeal as provided in the Disputes clause. In any event, the Contractor shall
proceed with completion of this Letter Contract, subject only to the Limitation of Government
Liability clause.
(1) After the Contracting Officer’s determination of price or fee, this Letter Contract shall be
governed by-
(i) All clauses required by the FAR on the date of execution of this Letter Contract for
either fixed-price or cost-reimbursement contracts, as determined by the Contracting
Officer under this paragraph (c);
(ii) All clauses required by law as of the date of the Contracting Officer’s determination;
and
(iii) Any other clauses, terms, and conditions mutually agreed upon.
(2) To the extent consistent with paragraph (c)(1) of this section, all clauses, terms, and
conditions included in this Letter Contract shall continue in effect, except those that by
their nature apply only to a Letter Contract.
(4) FAR Clause 52.204-21, Basic Safeguarding of Covered Contractor Information Systems (Jun 2016)
(a) Definitions. As used in this clause—
Covered contractor information system means an information system that is owned or
operated by a contractor that processes, stores, or transmits Federal contract
information.
Contract No. 75N92020C00007 Page 14
Federal contract information means information, not intended for public release, that is
provided by or generated for the Government under a contract to develop or deliver a
product or service to the Government, but not including information provided by the
Government to the public (such as on public websites) or simple transactional
information, such as necessary to process payments.
Information means any communication or representation of knowledge such as facts,
data, or opinions, in any medium or form, including textual, numerical, graphic,
cartographic, narrative, or audiovisual (Committee on National Security Systems
Instruction (CNSSI!) 4009).
Information system means a discrete set of information resources organized for the
collection, processing, maintenance, use, sharing, dissemination, or disposition of
information (44 U.S.C. 3502).
Safeguarding means measures or controls that are prescribed to protect information
systems.
(b) Safeguarding requirements and procedures.
(1) The Contractor shall apply the following basic safeguarding requirements and
procedures to protect covered contractor information systems. Requirements and
procedures for basic safeguarding of covered contractor information systems shall
include, at a minimum, the following security controls:
(i) Limit information system access to authorized users, processes acting on behalf of
authorized users, or devices (including other information systems).
(ii) Limit information system access to the types of transactions and functions that
authorized users are permitted to execute.
(iii) Verify and control/limit connections to and use of external information systems.
(iv) Control information posted or processed on publicly accessible information
systems.
v) Identify information system users, processes acting on behalf of users, or devices.
vi) Authenticate (or verify) the identities of those users, processes, or devices, as a
prerequisite to allowing access to organizational information systems.
vii) Sanitize or destroy information system media containing Federal Contract
Information before disposal or release for reuse.
viii) Limit physical access to organizational information systems, equipment, and the
respective operating environments to authorized individuals.
ix) Escort visitors and monitor visitor activity; maintain audit logs of physical access;
and control and manage physical access devices.
x) Monitor, control, and protect organizational communications (i.e., information
transmitted or received by organizational information systems) at the external
boundaries and key internal boundaries of the information systems.
xi) Implement subnetworks for publicly accessible system components that are
physically or logically separated from internal networks.
xii) Identify, report, and correct information and information system flaws in a timely
manner.
Contract No. 75N92020C00007 Page 15
(xiii) Provide protection from malicious code at appropriate locations within
organizational information systems.
(xiv) Update malicious code protection mechanisms when new releases are available.
(xv) Perform periodic scans of the information system and real-time scans of files from
external sources as files are downloaded, opened, or executed.
(2) Other requirements. This clause does not relieve the Contractor of any other specific
safeguarding requirements specified by Federal agencies and departments relating to
covered contractor information systems generally or other Federal safeguarding
requirements for controlled unclassified information (CUI) as established by Executive
Order 13556.
(c) Subcontracts. The Contractor shall include the substance of this clause, including this
paragraph (c), in subcontracts under this contract (including subcontracts for the
acquisition of commercial items, other than commercially available off-the-shelf items), in
which the subcontractor may have Federal contract information residing in or transiting
through its information system.
(End of clause)
(5) FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-
Commercial Items (Jul 2020)
(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses,
which are incorporated in this contract by reference, to implement provisions of law or
Executive orders applicable to acquisitions of commercial items:
(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or
Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further
Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in
subsequent appropriations acts (and as extended in continuing resolutions)).
(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or
Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L.
115-91).
(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video
Surveillance Services or Equipment. (Aug 2019) (Section 889(a)(1)(A) of Pub. L. 115-
232).
(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov
2015).
(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).
(6) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and
108-78 ( 19 U.S.C. 3805 note)).
(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting
Officer has indicated as being incorporated in this contract by reference to implement
Contract No. 75N92020C00007 Page 16
provisions of law or Executive orders applicable to acquisitions of commercial items:
[Contracting Officer check as appropriate.] — The parties agree to address the requirements of
this Article during definization of the contract.
___ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (JUNE 2020),
with Alternate | (Oct 1995) ( 41U.S.C.4704 and 10 U.S.C. 2402).
__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509)).
___ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment
Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the
American Recovery and Reinvestment Act of 2009.)
___ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN
2020) (Pub. L. 109-282) ( 31.U.S.C. 6101 note).
___ (5) [Reserved].
___ (6) 52.204-14, Service Contract Reporting Requirements (OcT 2016) (Pub. L. 111-117, section
743 of Div. C).
___ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery
Contracts (OcT 2016) (Pub. L. 111-117, section 743 of Div. C).
___ (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors
Debarred, Suspended, or Proposed for Debarment. (JUN 2020) (31 U.S.C. 6101 note).
___ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (OcT
2018) (41 U.S.C. 2313).
___ (10) [Reserved].
___ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (MAR
2020) (15 U.S.C. 657a).
__ (ii) Alternate | (MAR 2020) of 52.219-3.
___ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business
Concerns (Mar 2020) (if the offeror elects to waive the preference, it shall so indicate in its
offer) (15 U.S.C. 657a).
___ (ii) Alternate | (Mar 2020) of 52.219-4.
___ (13) [Reserved]
___ (14) (i) 52.219-6, Notice of Total Small Business Set-Aside (Mar 2020) of 52.219-
6 (15 U.S.C. 644).
__ (ii) Alternate | (MAR 2020) of 52.219-6 .
___ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (Mar 2020) (15 U.S.C. 644).
__ (ii) Alternate | (MAR 2020) of 52.219-7.
___ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).
___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Jun 2020) (15 U.S.C. 637(d)(4)).
__ (ii) Alternate | (Nov 2016) of 52.219-9.
__ (iii) Alternate II (Nov 2016) of 52.219-9.
___(iv)Alternate III (Jun 2020) of 52.219-9.
__ (v)Alternate IV (JUN 2020) oF 52.219-9
___ (18) (i) 52.219-13, Notice of Set-Aside of Orders (Mar 2020) (15 U.S.C. 644(r)).
___ (ii) Alternate | (Mar 2020) of 52.219-13.
___ (19) 52.219-14, Limitations on Subcontracting (Mar 2020) (15 U.S.C. 637(a)(14)).
___ (20) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan
1999) (15 U.S.C. 637(d)(4)(F)(i)).
___ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Mar
2020) (15 U.S.C. 657f).
Contract No. 75N92020C00007 Page 17
__ (22) (i) 52.219-28, Post Award Small Business Program Rerepresentation (May
2020) (15 U.S.C. 632(a)(2)).
___ (ii) Alternate | (MAR 2020) of 52.219-28.
__ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged
Women-Owned Small Business Concerns (Mar 2020) (15 U.S.C. 637(m)).
__ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small
Business Concerns Eligible Under the Women-Owned Small Business Program (Mar2020)
(15 U.S.C. 637(m)).
___ (25) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020)(15 U.S.C.
644(r)).
___ (26) 52.219-33, Nonmanufacturer Rule (Mar 2020) (15U.S.C. 637(a)(17)).
__ (27) 52.222-3, Convict Labor (Jun 2003) (E.0.11755).
___ (28) 52.222-19, Child Labor- Cooperation with Authorities and Remedies (Jan2020)
(E.0.13126)
___ (29) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).
___ (30) (i) 52.222-26, Equal Opportunity (Sep 2016) (E.0.11246).
___ (ii) Alternate | (Fes 1999) of 52.222-26.
___ (31) (i) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).
___ (ii) Alternate | (JuL 2014) of 52.222-35.
___ (32) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).
___ (ii) Alternate | (JuL 2014) of 52.222-36.
___ (33) 52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).
___ (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec
2010) (E.0. 13496).
___ (35) (i) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.O.
13627).
___ (ii) Alternate | (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).
___ (36) 52.222-54, Employment Eligibility Verification (Oct 2015). (Executive Order 12989). (Not
applicable to the acquisition of commercially available off-the-shelf items or certain other
types of commercial items as prescribed in 22.1803.)
___ (37) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA—Designated
Items (May 2008) ( 42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of
commercially available off-the-shelf items.)
___(ii) Alternate | (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the
acquisition of commercially available off-the-shelf items.)
__ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential
Hydrofluorocarbons (Jun 2016) (E.0. 13693).
___ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air
Conditioners (Jun 2016) (E.0. 13693).
___ (40) (i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.0.s
13423 and 13514).
___ (ii) Alternate | (Oct 2015) of 52.223-13.
___ (41) (i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.0.s 13423 and
13514).
__ (ii) Alternate | (Jun2014) of 52.223-14.
___ (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (May
2020) (42 U.S.C. 8259b).
___ (43) (i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OcT
Contract No. 75N92020C00007 Page 18
2015) (E.0.s 13423 and 13514).
___ (ii) Alternate | (JUN 2014) of 52.223-16.
___ (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun
2020) (E.0. 13513).
___ (45) 52.223-20, Aerosols (Jun 2016) (E.0. 13693).
__ (46) 52.223-21, Foams (Jun2016) (E.0. 13693).
__ (47) (i) 52.224-3 Privacy Training (JAN 2017) (5 U.S.C. 552 a).
__ (ii) Alternate | (JAN 2017) of 52.224-3.
__ (48) 52.225-1, Buy American-Supplies (May 2014) (41 U.S.C. chapter 83).
___ (49) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (May
2014) (41 U.S.C.chapter83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19
U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-
283, 110-138, 112-41, 112-42, and 112-43.
___ (ii) Alternate | (May 2014) of 52.225-3.
___ (iii) Alternate II (May 2014) of 52.225-3.
___ (iv) Alternate III (May 2014) of 52.225-3.
___ (50) 52.225-5, Trade Agreements (Oct 2019) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).
___ (51) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.0.’s, proclamations,
and statutes administered by the Office of Foreign Assets Control of the Department of the
Treasury).
___ (52) 52.225-26, Contractors Performing Private Security Functions Outside the United States
(Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal
Year 2008; 10 U.S.C. 2302Note).
__ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov2007) (42 U.S.C. 5150).
___ (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov2007)
(42 U.S.C. 5150).
___ (55) 52.229-12, Tax on Certain Foreign Procurements (JUN 2020).
___ (56) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb
2002) (41 U.S.C. 4505, 10 U.S.C. 2307/(f)).
___ (57) 52.232-30, Installment Payments for Commercial Items (Jan2017)
(41 U.S.C. 4505, 10 U.S.C. 2307(f)).
___ (58) 52.232-33, Payment by Electronic Funds Transfer-System for Award
Management (Oct2018) (31 U.S.C. 3332).
___ (59) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award
Management (Jul 2013) (31 U.S.C. 3332).
___ (60) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).
___ (61) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).
___ (62) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(13)).
__ (63) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (FEB
2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).
__ (ii) Alternate | (Apr 2003) of 52.247-64.
__ (iii) Alternate I! (Fe8 2006) of 52.247-64.
(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial
services, that the Contracting Officer has indicated as being incorporated in this contract by
reference to implement provisions of law or Executive orders applicable to acquisitions of
commercial items:
[Contracting Officer check as appropriate.]
___ (1) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter67).
Contract No. 75N92020C00007 Page 19
___ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May
2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).
___ (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price
Adjustment (Multiple Year and Option Contracts) (Aug
2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).
__ (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price
Adjustment (May 2014) ( 29U.S.C.206 and 41 U.S.C. chapter 67).
__ (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to
Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May
2014) (41 U.S.C. chapter 67).
___ (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to
Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67).
___ (7) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).
___ (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.0. 13706).
___ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020)
(42. U.S.C. 1792).
(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of
this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the
simplified acquisition threshold, as defined in FAR 2.101, on the date of award of this contract,
and does not contain the clause at 52.215-2, Audit and Records-Negotiation.
(1) The Comptroller General of the United States, or an authorized representative of the
Comptroller General, shall have access to and right to examine any of the Contractor’s
directly pertinent records involving transactions related to this contract.
(2) The Contractor shall make available at its offices at all reasonable times the records,
materials, and other evidence for examination, audit, or reproduction, until 3 years after
final payment under this contract or for any shorter period specified in FAR subpart 4.7,
Contractor Records Retention, of the other clauses of this contract. If this contract is
completely or partially terminated, the records relating to the work terminated shall be
made available for 3 years after any resulting final termination settlement. Records relating
to appeals under the disputes clause or to litigation or the settlement of claims arising under
or relating to this contract shall be made available until such appeals, litigation, or claims are
finally resolved.
(3) As used in this clause, records include books, documents, accounting procedures and
practices, and other data, regardless of type and regardless of form. This does not require
the Contractor to create or maintain any record that the Contractor does not maintain in
the ordinary course of business or pursuant to a provision of law.
(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this
clause, the Contractor is not required to flow down any FAR clause, other than those in this
paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the
extent of the flow down shall be as required by the clause-
(i) 52.203-13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509).
(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or
Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further
Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in
Contract No. 75N92020C00007 Page 20
subsequent appropriations acts (and as extended in continuing resolutions)).
(iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or
Provided by Kaspersky Lab and Other Covered Entities (JUL 2018) (Section 1634 of Pub. L.
115-91).
(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video
Surveillance Services or Equipment. (AUG 2019) (Section 889(a)(1)(A) of Pub. L. 115-232).
(v) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)), in
all subcontracts that offer further subcontracting opportunities. If the subcontract (except
subcontracts to small business concerns) exceeds the applicable threshold specified in
FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219-
8 in lower tier subcontracts that offer subcontracting opportunities.
(vi) 52.222-21, Prohibition of Segregated Facilities (APR 2015).
(vii) 52.222-26, Equal Opportunity (Sep 2015) (E.0.11246).
(viii) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).
(ix) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).
(x) 52.222-37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).
(xi) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC
2010) (E.0. 13496). Flow down required in accordance with paragraph (f) of FAR
clause 52.222-40.
xii) 52.222-41, Service Contract Labor Standards (Aug2018) (41 U.S.C. chapter 67).
xiii) (A) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.O
13627).
B) Alternate | (Mar2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).
xiv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to
Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements
(May2014) (41 U.S.C. chapter 67).
xv) 52.222-53, Exemption from Application of the Service Contract Labor Standards to
Contracts for Certain Services-Requirements (MAY2014) (41 U.S.C. chapter 67).
xvi) 52.222-54, Employment Eligibility Verification (OcT 2015) (E.0. 12989).
xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).
xviii) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).
xix) (A) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a),
B) Alternate | (Jan 2017) of 52.224-3.
(xx) 52.225-26, Contractors Performing Private Security Functions Outside the United
States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for
Fiscal Year 2008; 10 U.S.C. 2302 Note).
xxi) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun
2020) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR
clause 52.226-6.
(xxii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb
2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance
with paragraph (d) of FAR clause 52.247-64.
(2) While not required, the Contractor may include in its subcontracts for commercial items a
minimal number of additional clauses necessary to satisfy its contractual obligations.
(End of clause)
Contract No. 75N92020C00007 Page 21
PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS
SECTION J LIST OF ATTACHMENTS
1. Statement of Objectives
2. Ginkgo Contract Deliverables
Contract No. 75N92020C00007 Page 22
75N92020C00007 Ginkgo Bioworks, Inc
Attachment 1 Statement of Objectives
Statement of Objectives
Title: Rapid Acceleration of Diagnostics (RADx) — Advanced Technology Platforms (ATP) High-Throughput
Next Generation Sequencing based Molecular Diagnostic for SARS-CoV-2
Agency: National Institutes of Health (NIH)
1. Background
The National Institutes of Health (NIH), through the National Institute of Biomedical Imaging and
Bioengineering (NIBIB) has a requirement to provide up to $230M across multiple projects to rapidly
produce innovative SARS-CoV-2 diagnostic tests that will assist the public’s safe return to normal
activities. Rapid Acceleration of Diagnostics (RADx), is a fast-track technology development program
that leverages the NIH Point-of-Care Technology Research Network (POCTRN). RADx supports novel
solutions that build the U.S. capacity for SARS-CoV-2 testing up to 100-fold above what is achievable
with standard approaches. RADx is structured to deliver innovative testing strategies to the public as
soon as late summer 2020 and is an accelerated and comprehensive multi-pronged effort by NIH to
make SARS-CoV-2 testing readily available to every American.
2. Purpose and Objectives
RADx Advanced Technology Platforms (RADx-ATP) will increase testing capacity and throughput by
identifying and supporting existing and late stage testing platforms for detecting SARS-CoV-2, the virus
that causes COVID-19, that are far enough advanced to achieve rapid scale-up or expanded
geographical placement in a short amount of time. Through RADx ATP, NIH aims to increase capacity
and optimize throughput for point-of-care (POC) testing platforms and high-throughput laboratories.
To ensure that increased availability of advanced technology platforms are available to the public as
quickly as possible, NIH will leverage established partnerships with federal agencies, such as FDA, CDC,
CMS, ASPR/BARDA, the Department of Defense, as well as commercial and private entities to propel
technologies developed by RADx into widespread use.
The RADx-ATP program will focus on scaling up technologies, including improving existing high-
throughput platforms, to increase testing (i.e. detection) performance and increase the nation’s testing
capacity by one million tests per day.
Specifically RADx-ATP seeks to:
e Commercialize and scale production of existing technologies that are already or near FDA
authorization for SARS-CoV-2 detection.
e Facilitate the development of tests capable of differentiating SARS-CoV-2 vs. Influenza virus
detection
e Establish or expand regional testing hubs, to validate and perform clinical tests.
e Identify and support the resource needs to expand testing in underserved populations.
e Accelerate the development and implementation of tests for other infectious pathogens.
[oy
foray This initiative aims to increase the ability for widespread diagnostic testing of
the public to enable reopening and monitoring of industrial, educational and public sectors.
Page 1 of 3
75N92020C00007 Ginkgo Bioworks, Inc
Attachment 1 Statement of Objectives
3. Scope
Contracts for projects at an advanced stage of readiness (referred to as Phase Two or Work Package Two)
will cover the full range of activities needed to increase capacity and optimize throughput necessary to
distribute a viable product to the public. Supported by a RADx expert consulting team, NIH will provide
milestone-driven financial and in-kind resources to maximally accelerate progress. NIH will closely monitor
progress, assess milestone achievements, and evaluate the need for continued funding. Scope of work
executed under this contract, includes completing the validation, approval, and production processes in
order to deliver a viable product in a scaled up capacity to the U.S. public.
4. Performance Objectives (Required Results)
yay
A.
c.
D. The laboratory must be CLIA certified and currently operating with appropriate equipment and
trained staff.
E. f(b\(4)
”
The contractor must make the product available for independent regulatory/validation assessment
G. PO
H. The laboratory must use commercially available laboratory equipment and reagents, and have a
clear and detailed plan to address any supply chain shortage issues
I fe
J. The contractor must have a logistics plan in place for the collection and receipt of samples (e.g. have
identified and partnered with appropriate courier services to deliver samples)
k, Pe
Page 2 of 3
75N92020C00007 Ginkgo Bioworks, Inc
Attachment 1 Statement of Objectives
=
The contractor must have the ability to provide de-identified data to be shared with the NIH.
O. The contractor must provide a risk mitigation plan for each identified risk and update and inform
NIH on any changes/newly identified risks in an ongoing manner.
P. The contractor will provide a Quality Control Plan that includes applicable laws, without limitation,
health, safety, and environmental laws.
Q. The contractor shall promptly inform NIH of decisions about, or changes to, their facilities used in
the manufacturing of the Final Product.
R. The contractor shall not make changes to Process and/or Scaled up Process without the Contracting
Officer’s Representative (COR) prior written consent and otherwise as provided in the Quality
Control Plan.
S. The contractor must meet regularly (at least weekly) with NIH officials to update on progress toward
deliverables; anticipated and ongoing issues and problems; and timelines for deliverable completion
T. When guided by the COR, the contractor must collaborate and cooperate with external
organizations as needed to meet the contract goals in a manner which will not infringe contractor
commercial or intellectual property rights.
U. Any imported materials must be FDA-approved for use in the US.
V. The contractor must have the ability to deploy to high-risk, underserved, hard-to-reach
communities, with special focus on ease-of-use (including specimen collection mode, clear and easy
to understand instructions to facilitate widespread uptake) PO
W. The contractor must have a robust plan to continuously collect post-market data to support a
PMA/510(k) submission, share data with NIH, update clinical validity measures, monitor differences
in test results by type of specimen, collection device, user, setting, and other variables that may
impact test results.
5. Contract Type
Firm Fixed Price
6. Place of Performance
The place of performance shall be the Contractor’s place of performance:
Ginkgo Bioworks
23 - 27 Drydock Ave
Boston MA 02210
7. Period of Performance
The period of performance will be set for each contract awarded under RADx ATP.
The anticipated start date will be on or around July 29, 2020, for 12 months.
8. Deliverables/Delivery Schedule
See Letter Contract Attachment 2 Ginkgo Deliverables Schedule
Page 3 of 3
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TALIS BIOMEDICAL CORPORATION INHLBI Branch B Invoice
230 Constitution Dr 2115 East Jefferson St, MSC 8500
Menlo Park CA 940251109 Room 4B-432
Bethesda MD 20892-8500
TELEPHONE NO.
(17. CHECK iF REMITTANCE IS DIFFERENT AND PUT SUCH ADORESS IN OFFER 8b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW
IS CHECKED JSEE ADDENDUM
19, 20 2 2 23. 24,
ITEM NO. ‘SCHEDULE OF SUPPLIESISERVICES quantity [unit UNIT PRICE ‘AMOUNT
ITLE: RADx Tech - Talis Biomedical Highly
Scalable SARS-CoV-2 RNA Detection in Minutes
Period of Performance: 07/30/2020 to 07/29/2021
stage 1: Initiate Manufacturing Scale Up
1 pbigatea amount:
Project Data:
continued
(Use Reverse and/or Attach Additional Sheets as Necessary)
25. ACCOUNTING AND APPROPRIATION DATA, TOTAL AWARD AMOUNT (For Govt. Use Only)
See schedule $10,100,000.00
(27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA Oare (J ARE NOTATTACHED.
O27, CONTRACTIPURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ‘ADDENDA Glare [JARE NOTATTACHED.
28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN i C 29. AWARD OF CONTRACT: OFFER,
COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER DATED YOUR OFFER ON SOLICITATION (BLOCK 5),
ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH
SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED. HEREIN, IS ACCEPTED AS TO ITEMS:
Boa GE AE AEEERAGIEGUERAEIOR [S1a: UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)
Digitally signed by Allison M. Cristman -S
Allison M. Cristman -S px: 1020.07.30 13:16:18 -04'00'
Brian Coe (iui 29, 2020 1923 COT)
30b. NAME AND TITLE OF SIGNER (Type or print) [30c. DATE SIGNED [31b NAME OF CONTRACTING OFFICER (Type or print) |31c. DATE SIGNED
Brian Coe Chief Executive Officer Jul 29, 2020 llison M. Cristman 07/30/2020
UTHORIZED FOR LOCAL REPRODUCTION ‘STANDARD FORM 1449 (REV. 22012)
PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 63.212
19, 20. 21 2 23. 24
ITEM NO, ‘SCHEDULE OF SUPPLIESISERVICES. ‘QuantiTy | UNIT UNIT PRICE AMOUNT
151201-2020.300.COVID-19.DIAG-HN81 NIBIB OD
OFFICE OF THE DIRECTOR-25235 ALL OTHER SERVICES
(NON-FEDERAL SOURCES) -07/28/2020
Accounting Info:
08039820200DAD-2020-83-8100-EM81000000C-E-C4 400-40}
6-COVD-25235-9999-9999-9999-151201-2020.300.COVID-
19.DIAG-HN81 NIBIB OD OFFICE OF THE
DIRECTOR-07/28/2020-25235 ALL OTHER SERVICES
(NON-FEDERAL SOURCES) -8045207
Funded:
2 Stage 2: Design Verification
Project Data:
151201-2020.300.COVID-19.DIAG-HN81 NIBIB OD
OFFICE OF THE DIRECTOR-25235 ALL OTHER SERVICES
(NON-FEDERAL SOURCES) -07/28/2020
Accounting Info:
08039820200DAD-2020-83-8100-EM81000000C-E-C4400-40
6-COVD-25235-9999-9999-9999-151201-2020.300.COVID-
19.DIAG-HN81 NIBIB OD OFFICE OF THE
DIRECTOR-07/28/2020-25235 ALL OTHER SERVICES
(NON-FEDERAL SOURCES) -8045207
Continued ...
32a, QUANTITY IN COLUMN 21 HAS BEEN
RECEIVED INSPECTED ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:
32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32c. DATE 32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE
32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE
32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE
33. SHIP NUMBER [35. AMOUNT VERIFIED 36. PAYMENT
CORRECT FOR
39. SIR VOUCHER NUMBER
41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT.
41b, SIGNATURE AND TITLE OF CERTIFYING OFFICER
37. CHECK NUMBER
COMPLETE
PARTIAL
PARTIAL FINAL
38, SIR ACCOUNT NUMBER 40. PAID BY
|42a. RECEIVED BY (Print)
1c. DATE
42b. RECEIVED AT (Location)
|42c. DATE REC'D (YY/MM/DD)
42d, TOTAL CONTAINERS
‘STANDARD FORM 1449 (REV. 2/2012) BACK
|EFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE
CONTINUATION SHEET | 559 .9c00010 :
NAME OF OFFEROR OR CONTRACTOR
TALIS BIOMEDICAL CORPORATION
ITEM No. SUPPLIESISERVICES QUANTITY UNIT ——_UNITPRICE AMOUNT
(A) (B) (Cc) (D) (E) (F)
3 Stage 3: EUA Submission
4 Stage 4: Build and Validate First Cartridge
Manufacturing Line
5 Stage 5: Validate Second and Third Manufacturing
Line
NSN 7540-01-152-8067 ‘OPTIONAL FORM 336 (4-86)
‘Sponsored by GSA
FAR (48 CFR) 53.110
PART | — THE SCHEDULE
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
ARTICLE B.1. BRIEF DESCRIPTION OF SERVICES
This Letter Contract forms a preliminary understanding between Talis Biomedical Corporation and the National
Institutes of Health (NIH) and is issued as a result of the Rapid Acceleration of Diagnostics Tech (RADx Tech) fast
track program which supports the development and commercialization of innovative technologies to
significantly increase the U.S. testing capacity for SARS-CoV-2, the virus that causes COVID-19. Issuance of this
Letter Contract authorizes the Contractor to immediately begin the activities necessary to perform the
requirements as identified in the Statement of Objectives.
Talis Biomedical Corporation has developed a highly scalable LAMP-based testing instrument (Talis One) for
SARS-CoV-2 RNA detection, suited to the protection of vulnerable and highly exposed populations (e.g. eldercare
facilities, dialysis centers, cancer treatment centers, health care workers). The test is appropriate for NPS and NS
sampling either by a paraprofessional or layperson, and is completely automated, employing a single-use self-
contained cartridge and tabletop instrument. The scope of work executed under this contract, includes
completing the validation, approval, and production processes in order to deliver a viable product in a scaled up
capacity to the U.S. public.
This Letter Contract has been issued based on the application and preliminary work file submitted by the
contractor and subsequent documentation submitted during the Point of Care Technology Research Network
(POCTRN) review process. The contractor’s inability to meet the requirements as defined within this letter
contract and proposed within the POCTRN application process may result in the termination of the letter
contract in accordance with the termination clauses contained herein.
ARTICLE B.2. PRICES
a. The total Firm Fixed Price (FFP) amount for the letter contract is $10,100,000.
Payment Schedule
[See complete breakdown in Deliverable Schedule]
Milestone Amount
Stage 1: Initiate Manufacturing Scale Up Ka?
Stage 2: Design Verification
ARTICLE B.3. ADVANCE UNDERSTANDINGS
a. The parties acknowledge and agree that the situation around COVID-19 is highly dynamic, evolving
rapidly, and subject to significant uncertainty. The Letter Contract is being executed on an expedited
timeline to meet an urgent and compelling government need without the benefit of prior negotiation.
Thus, the parties will negotiate in good faith to ensure that the definitized contract reflects an
appropriate allocation of risk and responsibility and that it is consistent with the application and
preliminary work file submitted by the contractor and subsequent documentation submitted during the
application review process and the discussions between the parties that have taken place between date
of application submission through letter contract issuance. Until the Performance Work Statement
75N92020C00010 Page 4
(PWS) is finalized, the Statement of Objectives (SOO) will govern.
b. The parties anticipate that the definitive contract resulting from this Letter Contract will include a
negotiated firm fixed price not to exceed $25,400,000. Funding in the amount not to exceed
$10,100,000 is made available under this Letter Contract. The contractor shall not incur costs in excess
of this amount.
c. Commercial Item Status: The services provided by the Contractor under the Letter Contract and any
definitized contract constitute commercial item services, and the terms of any definitized contract will
reflect that understanding.
d. Performance Work Statement: The parties will negotiate the Performance Work Statement in the
process of contract definitization to fairly reflect the application and preliminary work file submitted by
the contractor and subsequent documentation submitted during the application review process and the
discussions between the parties that have taken place between application submission through letter
contract issuance.
e. HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to
include rating this order in accordance with 45 CFR Part 101, Subpart A—Health Resources Priorities and
Allocations System.
f. The parties agree prior to negotiate further the terms of milestone payments to include in the
definitized contract. In the negotiation, the parties will consider terms addressing liquidation of
milestone payments.
g. Successful performance under this contract requires the Contractor obtain and maintain an Emergency
Use Authorization (EUA) from the Food and Drug Administration (FDA); the Contractor shall copy the
NIH Program Manager on all FDA correspondence related to the project, including email
communications to and from the FDA. The FDA EAU services provided under this contract constitute a
commercial service to detect SARS-CoV-2.
h. Fair Pricing: The Rapid Acceleration of Diagnostics (RADx) application review process determined the
cost per test is competitive with the current market price. The Contractor must comply with applicable
federal law to ensure that prices to consumers are offered at fair market rate and at a rate consistent
with the objective to increase and improve testing in the United States.
i. In accordance with the goals of the RADx program, the testing capabilities produced under this contract
are to be for utilization within the U.S. and its territories.
j. Sharing Data and Reports: The Contractor will be required to provide data and reports (e.g.,
manufacturing, supply chain, production rates), which NIH will use to evaluate completion or
achievement of milestones, progress toward deliverables, and compliance with the requirements of the
contract. NIH may use the data to coordinate with other U.S. Government Agencies to accelerate
development and deployment of innovative COVID-19 diagnostic tests, and ensure effective stewardship
of federal funds. Sharing data within the federal government enables NIH to discuss the project’s
challenges and progress with federal agencies offering scientific, manufacturing, and logistics expertise.
To ensure that innovations are available to the public as quickly as possible, NIH will leverage
established partnerships with federal agencies, such as FDA, CDC, CMS, ASPR/BARDA, and the
75N92020C00010 Page 5
Department of Defense, and partnerships with State agencies to propel technologies developed by RADx
into widespread use.
k. Contractor Facilities: The contractor shall certify that they will maintain their Facility and Equipment in
satisfactory operating condition, as required to enable the contractor to manufacture the Final Product
to Specification in accordance with the Scaled up Process and all other applicable laws, regulations, rules
or orders. Routine repairs, preventive maintenance, and service contracts for the Facility and Equipment
shall be arranged by contractor at no additional cost to the Government.
|. Letter Contract Termination: In accordance with FAR 52.212-4(I), the Government reserves the right to
terminate this contract, or any part hereof, for its sole convenience. In the event of such termination,
the Contractor shall immediately stop work hereunder and shall immediately cause any and all of its
suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be
paid a percentage of the contract price reflecting the percentage of the work performed prior to the
notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the
Government using its standard record keeping system, have resulted from the termination. The
Contractor shall not be required to comply with the cost accounting standards or contract cost principles
for this purpose. This paragraph does not give the Government any right to audit the Contractor's
records. The Contractor shall not be paid for any work performed or costs incurred which reasonably
could have been avoided.
Note: If the contract is terminated for convenience, the contractor shall only stop work that incurs
additional expense, liability, or cost to the Government.
In accordance with FAR 52.212-4(m), the Government may terminate this contract, or any part hereof,
for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any
contract terms and conditions, or fails to provide the Government, upon request, with adequate
assurances of future performance. In the event of termination for cause, the Government shall not be
liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall
be liable to the Government for any and all rights and remedies provided by law. If it is determined that
the Government improperly terminated this contract for default, such termination shall be deemed a
termination for convenience.
m. Security and Privacy of Protected Health Information (PHI) processed under this contract: In the event
the Contractor meets the definition of either a Covered Entity or Business Associate under the Health
Insurance Portability and Accountability Act of 1996 (HIPAA), the Contractor shall comply with the
HIPAA regulatory standards set forth in the Code of Federal Regulations (CFR) 45 C.F.R. Part 160, Part
162, and Part 164. To the extent that the Contractor engages subcontractors or other Business
Associates to provide services under this Contract, and such Subcontractors or Business Associates will
receive or create PHI on behalf of the Contractor, the Contractor shall obtain satisfactory assurances
from its business associate that the business associate will appropriately safeguard the PHI. The
satisfactory assurances must be in writing, whether in the form of a contract or other agreement
between the Contractor and the business associate. In the event of a security or privacy breach
applicable to PHI processed under this contract, in addition to following the procedures set forth in 45
C.F.R. Part 164, the Contractor shall also immediately notify the NIH via the Contracting Officer (CO) and
the Contracting Officer's Representative (COR).
n. Information and/or Physical Security: The parties agree to address HHS Information Security and Privacy
75N92020C00010 Page 6
Requirements, as applicable, during definitization of the contract.
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
ARTICLE C.1. STATEMENT OF OBJECTIVES
Independently and not as an agent of the Government, the Contractor shall furnish all the necessary
services, qualified personnel, material, equipment, and facilities, not otherwise provided by the
Government as needed to perform the Statement of Objectives, dated July 29, 2020, set forth in SECTION
J—List of Attachments, attached hereto and made a part of this contract. Work to be performed shall be
consistent with the application and preliminary work file submitted by the Contractor and subsequent
documentation submitted during the application review process and the discussions between the parties
that have taken place between date of application submission through letter contract issuance.
ARTICLE C.2. REPORTING REQUIREMENTS
All reports required herein shall be submitted in electronic format only. All electronic reports submitted shall be
compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents
for Section 508 compliance, including guidance and specific checklists, by application, can be found at:
http://www. hhs.gov/web/508/index.htm! under "Making Files Accessible."
Reporting Requirements TBD
Placeholder: De-identified data for NIH research database
SECTION D — PACKAGING, MARKING, AND SHIPPING
There are no additional instructions or specifications applicable to this contract other than the delivery
instructions contained herein.
SECTION E - INSPECTION AND ACCEPTANCE
a. The Contracting Officer or the duly authorized Contracting Officer's Representative (COR) will perform
inspection and acceptance of materials and services to be provided.
b. Inspection and acceptance will be performed utilizing the success criteria outlined in the deliverable
schedule.
SECTION F - DELIVERIES OR PERFORMANCE
ARTICLE F.1. PERIOD OF PERFORMANCE
The period of performance of the contract is anticipated to be July 30, 2020 through July 29, 2021.
ARTICLE F.2. DELIVERIES
Satisfactory performance shall be deemed to occur upon performance of the work described in the Statement of
Objectives Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or
the duly authorized representative, in accordance with the stated delivery schedule.
75N92020C00010 Page 7
The deliverables shall be submitted to the Contracting Officer or designated Contracting Officer’s Representative
(Cor).
SECTION G - CONTRACT ADMINISTRATION DATA
ARTICLE G.1. CONTRACTING OFFICER (CO)
The following Contracting Officer (CO) will represent the Government for the purpose of
this contract:
Name: Allison Cristman
Telephone: 301-827-7703
Email: allison.cristman@nih.gov
The Contracting Officer is the only person with authority to act as agent of the Government
under this contract. Only the Contracting Officer has authority to:
1) direct or negotiate any changes in the Statement of Objectives or Performance Work
Statement;
2) modify or extend the period of performance;
3) change the delivery schedule;
4) authorize reimbursement to the Contractor for any costs incurred during the performance of this
contract;
5) otherwise change any terms and conditions of this contract; or
6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in
Section K of the contract.
All correspondence (including invoices) that proposes or otherwise involves waivers, deviations, or
modifications to requirement shall be provided to the CO issuing the task order and the COR supporting
the CO.
ARTICLE G.2. CONTRACTING OFFICER'S REPRESENTATIVE (COR)
The following Contracting Officer's Representative (COR) is anticipated to represent the Government for
the purpose of this contract:
Olga Hartman, Ph.D.
Phone: 443-350-7696
Email: olga.hartman.civ@mail.mil
The COR is responsible for:
(1) monitoring the Contractor's technical progress, including the surveillance and assessment of
performance and recommending to the Contracting Officer changes in requirements;
(2) interpreting the statement of objectives and any other technical performance requirements;
(3) performing technical evaluation as required;
(4) performing technical inspections and acceptances required by this contract; and
(5) assisting in the resolution of technical problems encountered during performance.
The Government may unilaterally change the COR designation.
75N92020C00010 Page 8
ARTICLE G.3. PRIMARY PROGRAM MANAGER
The Primary Program Manager specified in this contract is considered to be essential to work
performance. At least 30 days prior to any changes to the individual listed below to other programs or
contracts (or as soon as reasonably possible, if an individual must be replaced, for example, as a result of
leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit
comprehensive justification for the change request (including proposed substitutions for primary program
manager) to permit evaluation by the Government of the impact on performance under this contract. The
Contractor shall not replace any primary program manager without the written consent of the Contracting
Officer. The Government may modify the contract to add or delete primary program manager at the
request of the contractor or Government. In no case shall the individual's effort exceed 100% across all
contracts.
For purposes of this article, ill be the Primary Program Manager.
ARTICLE G.4. INVOICE SUBMISSION
In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include
the following information on the face page of all contract payment requests:
a. The Contract Title is: RADx Tech — Talis Biomedical Highly Scalable SARS-CoV-2 RNA Detection in
Minutes
b. The Contract Line Items are defined within Section 20, Schedule of Supplies/Services of the Standard
Form 1449,
c. Invoice Instructions are attached and made part of this contract. The Contractor shall follow the
attached instructions and submission procedures specified below to meet the requirements of a "proper
invoice" pursuant to FAR Subpart 32.9, Prompt Payment.
1. Payment requests shall be submitted to the offices identified below. Do not submit supporting
documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your payment request unless
specified elsewhere in the contract or requested by the Contracting Officer.
a. One copy of the invoice shall be submitted to the approving official at the following email
addresses:
NHLBI Branch B Central Email Box: NHLBIContractsBranchB@mail.nih.gov
NIH Centralized Invoice Email Box: invoicing@nih.gov
2. E-Mail: The Contractor shall submit an electronic copy of the payment request to the approving
official. The payment request shall be transmitted as an attachment via e-mail to the address listed
above in one of the following formats: MSWord, MS Excel, or Adobe Portable Document Format
(PDF). Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall
include the Contractor's name, contract number, and unique invoice number.
3. In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall
include the following information on the face page of all payment requests (invoices):
a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is NHLBI.
b. Central Point of Distribution. For the purpose of this contract, the Central Point of Distribution is
NHLBI Branch B Invoices.
75N92020C00010 Page 9
c. Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall
identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number
that appears after the Contractor's name on the face page of the contract. [Note: A VIN is
assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to
include the VIN number.] \f the Contractor has neither a TIN, DUNS, or VIN, contact the
Contracting Officer.
d. DUNS or DUNS+4 Number. The DUNS number must identify the Contractor's name and address
exactly as stated in the contract and as registered in the Central Contractor Registration (CCR)
database. If the Contractor does not have a valid DUNS number, it shall identify the Vendor
Identification Number (VIN) on the payment request. The VIN is the number that appears after
the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts
awarded on or after June 4, 2007, and any existing contract modified to include the VIN
number.] \f the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.
e. Invoice Matching Option. This contract requires a two-way match.
f. Unique Invoice Number. Each payment request must be identified by a unique invoice number,
which can only be used one time regardless of the number of contracts or orders held by an
organization.
g. PRISM/NBS Line Item Number and associated PRISM/NBS Line Item Period of Performance (see
Section B — PRICES/OPTION).
d. Inquiries regarding payment of invoices shall be directed to the designated billing office, 301-496-6088.
SECTION H - ADDITONAL CONTRACT CLAUSES
ARTICLE H.1. SUBCONTRACTING PROVISIONS
The parties agree to address the requirements of this Article during definitization of the contract.
a. Small Business Subcontracting Plan
1. The Small Business Subcontracting Plan, dated TBD is attached hereto and made a part of this
contract.
2. The failure of any Contractor or subcontractor to comply in good faith with FAR Clause 52.219-8,
entitled "Utilization of Small Business Concerns" incorporated in this contract and the attached
Subcontracting Plan, will be a material breach of such contract or subcontract and subject to the
remedies reserved to the Government under FAR Clause 52.219-16 entitled, "Liquidated
Damages-Subcontracting Plan."
b. Subcontracting Reports
The Contractor shall submit the following Subcontracting reports electronically via the "electronic
Subcontracting Reporting System (eSRS) at http://www.esrs.gov.
1. Individual Subcontract Reports (ISR)
Regardless of the effective date of this contract, the Report shall be due on the following
75N92020C00010 Page 10
dates for the entire life of this contract:
April 30", October 30"
Expiration Date of Contract
Summary Subcontract Report (SSR)
2. Regardless of the effective date of this contract, the Summary Subcontract Report shall be
submitted annually on the following date for the entire life of this contract:
October 30"
For both the Individual and Summary Subcontract Reports, the Contracting Officer shall be included
as a contact for notification purposes at the following e-mail address:
Allison Cristman, Branch Chief
allison.cristman@nih.gov
ARTICLE H.2. CONFIDENTIALITY OF INFORMATION
a. Confidential information, as used in this article, means information or data of a personal
nature about an individual, or proprietary information or data submitted by or pertaining
to an institution or organization.
b. The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this
contract specific information and/or categories of information which the Government will
furnish to the Contractor or that the Contractor is expected to generate which is confidential.
Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such
confidential information from time to time during the performance of the contract. Failure to
agree will be settled pursuant to the "Disputes" clause.
c. If it is established elsewhere in this contract that information to be utilized under this contract, or
a portion thereof, is subject to the Privacy Act, the Contractor will follow the rules and procedures
of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and
policies, with respect to systems of records determined to be subject to the Privacy Act.
d. Confidential information, as defined in paragraph (a) of this article, shall not be disclosed without
the prior written consent of the individual, institution, or organization.
e. Whenever the Contractor is uncertain with regard to the proper handling of material under the
contract, or if the material in question is subject to the Privacy Act or is confidential information
subject to the provisions of this article, the Contractor should obtain a written determination
from the Contracting Officer prior to any release, disclosure, dissemination, or publication.
f. Contracting Officer determinations will reflect the result of internal coordination with
appropriate program and legal officials.
g. The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping
provisions in other Federal, State or local laws.
75N92020C00010 Page 11
ARTICLE H.3. PUBLICATION AND PUBLICITY
In addition to the requirements set forth in HHSAR Clause 352.227-70, Publications and Publicity
incorporated by reference in SECTION | of this contract, the Contractor shall acknowledge the
support of the National Institutes of Health whenever publicizing the work under this contract in any
media by including an acknowledgment substantially as follows:
"This project has been funded in whole or in part with Federal funds from the National Institute
of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health
and Human Services, under Contract No. 75N92020C00010."
ARTICLE H.4. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE
Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in
NIH funded programs is encouraged to report such matters to the HHS Inspector General's Office
in writing or on the Inspector General's Hotline. The toll free number is 1-800-HHS-TIPS (1-800-
447-8477). All telephone calls will be handled confidentially. The website to file a complaint on-
line is: http://oig.hhs.gov/fraud/hotline/ and the mailing address is:
US Department of Health and Human Services Office of Inspector
General
ATTN: OIG HOTLINE OPERATIONS
P.O. Box 23489 Washington, D.C. 20026
PART II - CONTRACT CLAUSES
SECTION | - CONTRACT CLAUSES
ARTICLE 1.1. ADDITIONAL CONTRACT CLAUSES
The parties agree to address the requirements of this Article during definitization of the contract.
This contract incorporates the following clauses by reference, (unless otherwise noted), with the same force and
effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.
FAR Clause 52.212-3, Offeror Representations and Certifications — Commercial Items (Jun 2020)
FAR Clause 52.212-4, Contract Terms and Conditions —- Commercial Items (Oct 2018)
FAR Clause 52.203-13, Contractor Code of Business Ethics and Conduct (October 2015)
FAR Clause 52.204-13, System for Award Management Maintenance
FAR Clause 52.204-18, Commercial and Government Entity Code Maintenance (July 2016)
FAR Clause 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or
Provided by Kaspersky Lab and Other Covered Entities
g. FAR Clause 52.209-10, Prohibition on Contracting With Inverted Domestic Corporations(November
2015)
h. FAR Clause 52.222-4, Contract Work Hours and Safety Standards - Overtime Compensation -General
(May 2014)
i. FAR Clause 52.222-29, Notification of Visa Denial (April 2015)
j. FAR Clause 52.224-1, Privacy Act Notification (April 1984)
k. FAR Clause 52.224-2, Privacy Act (April 1984)
moans
75N92020C00010 Page 12
I. FAR Clause 52.227-1, Authorization and Consent (June 2020)
m. FAR Clause 52.227-3, Patent Indemnity (April 1984)
n. FAR Clause 52.227-11, Patent Rights - Ownership by the Contractor (May 2014)
o. FAR Clause 52.227-14, Rights in Data - General (May 2014)
p. FAR Clause 52.227-14, Rights in Data - General (May 2014) Alternate II (Dec 2007)
q. FAR Clause 52.232-40, Providing Accelerated Payments to Small Business Subcontractors
ARTICLE 1.2. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT
a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES
Additional clauses other than those listed below which are based on the type of contract/Contractor
shall be determined during negotiations. This contract incorporates the following clauses in full text.
1. FAR 52.216-23 - EXECUTION AND COMMENCMENT OF WORK (APR 1984)
The Contractor shall indicate acceptance of this letter contract by signing One Copy of the contract
and returning them to the Contracting Officer not later than July 30, 2020. Upon acceptance by both
parties, the Contractor shall proceed with performance of the work, including purchase of necessary
materials.
2. FAR 52.216-24 - LIMITATION OF GOVERNMENT LIABILITY (APR 1984)
(a) In performing this contract, the Contractor is not authorized to make expenditures or incur
obligations exceeding $10,100,000 dollars.
(b) The maximum amount for which the Government shall be liable if this contract is terminated is
$10,100,000 dollars.
3. FAR 52.216-25 - CONTRACT DEFINITIZATION (OCT 2010)
(a) A Firm Fixed Price (FFP) definitive contract is contemplated. The Contractor agrees to begin
promptly negotiating with the Contracting Officer the terms of a definitive contract that will include
(1) all clauses required by the Federal Acquisition Regulation (FAR) on the date of execution of the
letter contract, (2) all clauses required by law on the date of execution of the definitive contract, and
(3) any other mutually agreeable clauses, terms, and conditions. The Contractor agrees to submit a
Firm Fixed Price proposal, including data other than certified cost or pricing data, in accordance with
FAR 15.408, Table 15-2, supporting its proposal.
(b) The schedule for definitizing this contract is:
Target date for start of negotiations: August 17, 2020
Target date for definitization: September 1, 2020
Definitization Schedule Date
Statement of Objectives Review July 23, 2020
Issuance of Letter Contract July 30, 2020
Letter Contract Post Award Kick Off meeting | July 31, 2020
Contractor Technical and Revised Price August 10, 2020
75N92020C00010 Page 13
Proposal Submittal, to include
Subcontracting Plans (if applicable)
Request Other Than Certified Cost or Pricing | August 14, 2020
Data
POTQ / Technical Evaluation August 17, 2020
Negotiations Start August 18, 2020
Definitization of Letter Contract September 1, 2020
(c) If agreement on a definitive contract to supersede this letter contract is not reached by the target
date in paragraph (b) of this section, or within any extension of it granted by the Contracting
Officer, the Contracting Officer may, with the approval of the head of the contracting activity,
determine a reasonable price or fee in accordance with subpart 15.4 and part 31 of the FAR,
subject to Contractor appeal as provided in the Disputes clause. In any event, the Contractor shall
proceed with completion of the contract, subject only to the Limitation of Government Liability
clause.
(1) After the Contracting Officer’s determination of price or fee, the contract shallbe governed
by-
(i) All clauses required by the FAR on the date of execution of this letter contract for
either fixed-price or cost-reimbursement contracts, as determined by the Contracting
Officer under this paragraph (c);
(ii) All clauses required by law as of the date of the Contracting Officer's determination;
and
(iii) Any other clauses, terms, and conditions mutually agreed upon.
(2) To the extent consistent with paragraph (c)(1) of this section, all clauses, terms, and
conditions included in this letter contract shall continue in effect, except those that by their
nature apply only to a letter contract.
4. FAR Clause 52.204-21, Basic Safeguarding of Covered Contractor Information Systems (Jun 2016)
(a) Definitions. As used in this clause—
Covered contractor information system means an information system that is owned or
operated by a contractor that processes, stores, or transmits Federal contract
information.
Federal contract information means information, not intended for public release, that is
provided by or generated for the Government under a contract to develop or deliver a
product or service to the Government, but not including information provided by the
Government to the public (such as on public websites) or simple transactional
information, such as necessary to process payments.
Information means any communication or representation of knowledge such as facts,
data, or opinions, in any medium or form, including textual, numerical, graphic,
cartographic, narrative, or audiovisual (Committee on National Security Systems
Instruction (CNSSI) 4009).
Information system means a discrete set of information resources organized for the
75N92020C00010 Page 14
75N92020C00010
collection, processing, maintenance, use, sharing, dissemination, or disposition of
information (44 U.S.C. 3502).
Safeguarding means measures or controls that are prescribed to protect information
systems.
(b) Safeguarding requirements and procedures.
(1) The Contractor shall apply the following basic safeguarding requirements and
procedures to protect covered contractor information systems. Requirements and
procedures for basic safeguarding of covered contractor information systems shall
include, at a minimum, the following security controls:
(i) Limit information system access to authorized users, processes acting on behalf of
authorized users, or devices (including other information systems).
(ii) Limit information system access to the types of transactions and functions that
authorized users are permitted to execute.
(iii) Verify and control/limit connections to and use of external information systems.
(iv) Control information posted or processed on publicly accessible information
systems.
(v) Identify information system users, processes acting on behalf of users, or devices.
(vi) Authenticate (or verify) the identities of those users, processes, or devices, as a
prerequisite to allowing access to organizational information systems.
(vii) Sanitize or destroy information system media containing Federal Contract
Information before disposal or release for reuse.
(viii) Limit physical access to organizational information systems, equipment, and the
respective operating environments to authorized individuals.
(ix) Escort visitors and monitor visitor activity; maintain audit logs of physical access;
and control and manage physical access devices.
(x) Monitor, control, and protect organizational communications (i.e., information
transmitted or received by organizational information systems) at the external
boundaries and key internal boundaries of the information systems.
(xi) Implement subnetworks for publicly accessible system components that are
physically or logically separated from internal networks.
(xii) Identify, report, and correct information and information system flaws in a timely
manner.
(xiii) Provide protection from malicious code at appropriate locations within
Page 15
organizational information systems.
(xiv) Update malicious code protection mechanisms when new releases are available.
(xv) Perform periodic scans of the information system and real-time scans of files from
external sources as files are downloaded, opened, or executed.
(2) Other requirements. This clause does not relieve the Contractor of any other specific
safeguarding requirements specified by Federal agencies and departments relating to
covered contractor information systems generally or other Federal safeguarding
requirements for controlled unclassified information (CUI) as established by Executive
Order 13556.
(c) Subcontracts. The Contractor shall include the substance of this clause, including this
paragraph (c), in subcontracts under this contract (including subcontracts for the
acquisition of commercial items, other than commercially available off-the-shelf items), in
which the subcontractor may have Federal contract information residing in or transiting
through its information system.
(End of clause)
5. FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-
Commercial Items (Jul 2020)
(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses,
which are incorporated in this contract by reference, to implement provisions of law or
Executive orders applicable to acquisitions of commercial items:
(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or
Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further
Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in
subsequent appropriations acts (and as extended in continuing resolutions)).
(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or
Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L.
115-91).
(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video
Surveillance Services or Equipment. (Aug 2019) (Section 889(a)(1)(A) of Pub. L. 115-
232).
(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov
2015).
(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).
(6) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and
108-78 ( 19 U.S.C. 3805 note)).
(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting
75N92020C00010 Page 16
Officer has indicated as being incorporated in this contract by reference to implement
provisions of law or Executive orders applicable to acquisitions of commercial items:
Selections will be made by the Contracting Officer during definitization.
___ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (JUNE 2020),
with Alternate | (Oct 1995) ( 41U.S.C.4704 and 10 U.S.C. 2402).
___ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509)).
___ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment
Act of 2009 (Jun 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the
American Recovery and Reinvestment Act of 2009.)
__ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN
2020) (Pub. L. 109-282) ( 31 U.S.C. 6101 note).
___ (5) [Reserved].
___ (6) 52.204-14, Service Contract Reporting Requirements (OcT 2016) (Pub. L. 111-117, section
743 of Div. C).
___(7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery
Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).
___ (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors
Debarred, Suspended, or Proposed for Debarment. (JUN 2020) (31 U.S.C. 6101 note).
___ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (OcT
2018) (41 U.S.C. 2313).
___ (10) [Reserved].
___ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (MAR
2020) (15 U.S.C. 657a).
__ (ii) Alternate | (Mar 2020) of 52.219-3.
___ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business
Concerns (Mar 2020) (if the offeror elects to waive the preference, it shall so indicate in its
offer) (15 U.S.C. 657a).
__ (ii) Alternate | (Mar 2020) of 52.219-4.
___ (13) [Reserved]
__ (14) (i) 52.219-6, Notice of Total Small Business Set-Aside (Mar 2020) of 52.219-
6 (15 U.S.C. 644).
___ (ii) Alternate | (Mar 2020) of 52.219-6.
___ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (Mar 2020) (15 U.S.C. 644).
__ (ii) Alternate | (Mar 2020) of 52.219-7.
___ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).
___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Jun 2020) (15 U.S.C. 637(d)(4)).
ii) Alternate | (Nov 2016) of 52.219-9.
iii) Alternate II (Nov 2016) of 52.219-9.
iv)Alternate III (Jun 2020) of 52.219-9.
___(v)AlterNATE IV (JUN 2020) OF 52.219-9
___ (18) (i) 52.219-13, Notice of Set-Aside of Orders (Mar 2020) (15 U.S.C. 644(r)).
___ (ii) Alternate | (Mar 2020) of 52.219-13.
___(19) 52.219-14, Limitations on Subcontracting (Mar 2020) (15 U.S.C. 637(a)(14)).
___ (20) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan
1999) (15 U.S.C. 637(d)(4)(F)(i)).
___ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Mar
2020) (15 U.S.C. 657f).
75N92020C00010 Page 17
__ (22) (i) 52.219-28, Post Award Small Business Program Rerepresentation (May
2020) (15 U.S.C. 632(a)(2)).
___(ii) Alternate | (MAR 2020) of 52.219-28.
___ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged
Women-Owned Small Business Concerns (Mar 2020) (15 U.S.C. 637(m)).
___ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small
Business Concerns Eligible Under the Women-Owned Small Business Program (Mar2020)
(15 U.S.C. 637(m)).
___ (25) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020)(15 U.S.C.
644(r)).
___ (26) 52.219-33, Nonmanufacturer Rule (Mar 2020) (15U.S.C. 637(a)(17)).
__ (27) 52.222-3, Convict Labor (Jun 2003) (£.0.11755).
___ (28) 52.222-19, Child Labor- Cooperation with Authorities and Remedies (Jan2020)
(E.0.13126)
___ (29) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).
__ (30) (i) 52.222-26, Equal Opportunity (Sep 2016) (E.0.11246).
__ (ii) Alternate | (Fes 1999) of 52.222-26.
___ (31) (i) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).
___ (ii) Alternate | (JUL 2014) of 52.222-35.
___ (32) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).
__ (ii) Alternate | (JUL 2014) of 52.222-36.
__ (33) 52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).
___ (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec
2010) (E.0. 13496).
___ (35) (i) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.0.
13627).
__ (ii) Alternate | (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).
___ (36) 52.222-54, Employment Eligibility Verification (Oct 2015). (Executive Order 12989). (Not
applicable to the acquisition of commercially available off-the-shelf items or certain other
types of commercial items as prescribed in 22.1803.)
___ (37) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA—Designated
Items (May 2008) ( 42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of
commercially available off-the-shelf items.)
___ (ii) Alternate | (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the
acquisition of commercially available off-the-shelf items.)
___ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential
Hydrofluorocarbons (Jun 2016) (E.0. 13693).
___ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air
Conditioners (Jun 2016) (E.O. 13693).
___ (40) (i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.0.s
13423 and 13514).
___ (ii) Alternate | (Oct 2015) of 52.223-13.
___ (41) (i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O0.s 13423 and
13514).
__ (ii) Alternate | (Jun2014) of 52.223-14.
___ (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (May
2020) (42 U.S.C. 8259b).
___ (43) (i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (Oct
75N92020C00010 Page 18
2015) (E.0.s 13423 and 13514).
___(ii) Alternate | (JUN 2014) of 52.223-16.
___ (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun
2020) (E.0. 13513).
___ (45) 52.223-20, Aerosols (Jun 2016) (E.0. 13693).
__ (46) 52.223-21, Foams (Jun2016) (E.0. 13693).
__ (47) (i) 52.224-3 Privacy Training (JAN 2017) (5 U.S.C. 552 a).
__ (ii) Alternate | (JAN 2017) of 52.224-3.
___ (48) 52.225-1, Buy American-Supplies (May 2014) (41 U.S.C. chapter 83).
__ (49) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (May
2014) (41 U.S.C.chapter83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19
U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-
283, 110-138, 112-41, 112-42, and 112-43.
___ (ii) Alternate | (May 2014) of 52.225-3.
__ (iii) Alternate II (May 2014) of 52.225-3.
___ (iv) Alternate III (May 2014) of 52.225-3.
___ (50) 52.225-5, Trade Agreements (Oct 2019) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).
___ (51) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.0.’s, proclamations,
and statutes administered by the Office of Foreign Assets Control of the Department of the
Treasury).
___ (52) 52.225-26, Contractors Performing Private Security Functions Outside the United States
(Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal
Year 2008; 10 U.S.C. 2302Note).
___ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov2007) (42 U.S.C. 5150).
___ (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov2007)
(42 U.S.C. 5150).
___ (55) 52.229-12, Tax on Certain Foreign Procurements (JUN 2020).
___ (56) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb
2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).
___ (57) 52.232-30, Installment Payments for Commercial Items (Jan2017)
(41 U.S.C. 4505, 10 U.S.C. 2307(f)).
___ (58) 52.232-33, Payment by Electronic Funds Transfer-System for Award
Management (Oct2018) (31 U.S.C. 3332).
___ (59) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award
Management (Jul 2013) (31 U.S.C. 3332).
___ (60) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).
___ (61) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).
__ (62) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(13)).
__ (63) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (FEB
2006) (46 U.S.C. Appx. 1241(b) and 10 | 2631).
___ (ii) Alternate | (Apr 2003) of 52.247-64.
__ (iii) Alternate II (Fes 2006) of 52.247-64.
(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial
services, that the Contracting Officer has indicated as being incorporated in this contract by
reference to implement provisions of law or Executive orders applicable to acquisitions of
commercial items:
[Contracting Officer check as appropriate.)
___ (1) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter67).
75N92020C00010 Page 19
___(2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May
2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).
___ (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price
Adjustment (Multiple Year and Option Contracts) (Aug
2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).
__ (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price
Adjustment (May 2014) ( 29U.S.C.206 and 41 U.S.C. chapter 67).
__ (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to
Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May
2014) (41 U.S.C. chapter 67).
__ (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to
Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67).
___ (7) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).
___ (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.O. 13706).
___ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020)
(42.U.S.C. 1792).
(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of
this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the
simplified acquisition threshold, as defined in FAR 2.101, on the date of award of this contract,
and does not contain the clause at 52.215-2, Audit and Records-Negotiation.
(1) The Comptroller General of the United States, or an authorized representative of the
Comptroller General, shall have access to and right to examine any of the Contractor’s
directly pertinent records involving transactions related to this contract.
(2) The Contractor shall make available at its offices at all reasonable times the records,
materials, and other evidence for examination, audit, or reproduction, until 3 years after
final payment under this contract or for any shorter period specified in FAR subpart 4.7,
Contractor Records Retention, of the other clauses of this contract. If this contract is
completely or partially terminated, the records relating to the work terminated shall be
made available for 3 years after any resulting final termination settlement. Records relating
to appeals under the disputes clause or to litigation or the settlement of claims arising under
or relating to this contract shall be made available until such appeals, litigation, or claims are
finally resolved.
(3) As used in this clause, records include books, documents, accounting procedures and
practices, and other data, regardless of type and regardless of form. This does not require
the Contractor to create or maintain any record that the Contractor does not maintain in
the ordinary course of business or pursuant to a provision of law.
(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this
clause, the Contractor is not required to flow down any FAR clause, other than those in this
paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the
extent of the flow down shall be as required by the clause-
(i) 52.203-13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509).
(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or
Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further
Continuing Appropriations Act, 2015 (Pub. L_ 113-235) and its successor provisions in
75N92020C00010 Page 20
subsequent appropriations acts (and as extended in continuing resolutions)).
(iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or
Provided by Kaspersky Lab and Other Covered Entities (JuL 2018) (Section 1634 of Pub. L.
115-91).
(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video
Surveillance Services or Equipment. (AUG 2019) (Section 889(a)(1)(A) of Pub. L. 115-232).
(v) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)), in
all subcontracts that offer further subcontracting opportunities. If the subcontract (except
subcontracts to small business concerns) exceeds the applicable threshold specified in
FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219-
8 in lower tier subcontracts that offer subcontracting opportunities.
(vi) 52.222-21, Prohibition of Segregated Facilities (APR 2015).
(vii) 52.2 Equal Opportunity (Sep 2015) (£.0.11246).
(viii) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212),
(ix) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).
(x) 52.222-37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).
(xi) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec
2010) (E.0. 13496). Flow down required in accordance with paragraph (f) of FAR
clause 52.222-40.
(xii) 52.222-41, Service Contract Labor Standards (Aug2018) (41 U.S.C. chapter 67).
(xiii) (A) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U chapter 78 and E.O
13627).
(B) Alternate | (Mar2015) of 52.222-50 (22 U.S.C. chapter 78 and E.0. 13627).
(xiv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to
Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements
(May2014) (41 U.S.C. chapter 67).
(xv) 52.222-53, Exemption from Application of the Service Contract Labor Standards to
Contracts for Certain Services-Requirements (MAY2014) (41 U.S.C. chapter 67).
(xvi) 52.222-54, Employment Eligibility Verification (Oct 2015) (E.O. 12989).
(xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).
(xviii) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).
(xix) (A) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).
(B) Alternate | (Jan 2017) of 52.224-3.
(xx) 52.225-26, Contractors Performing Private Security Functions Outside the United
States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for
Fiscal Year 2008; 10 U.S.C. 2302 Note).
(xxi) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun
2020) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR
clause 52.226-6.
(xxii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb
2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance
with paragraph (d) of FAR clause 52.247-64.
(2) While not required, the Contractor may include in its subcontracts for commercial items a
minimal number of additional clauses necessary to satisfy its contractual obligations.
(End of clause)
PART III - LIST OF DOCUMENTS AND OTHER ATTACHMENTS
75N92020C00010 Page 21
SECTION J LIST OF ATTACHMENTS
1. Statement of Objectives
a. Appendix 1— Schedule of Deliverables, Payment Schedule
75N92020C00010 Page 22
Attachment 1 — Statement of Objectives
Statement of Objectives
Program Title: Rapid Acceleration of Diagnostics (RADx) — Tech
Project Title: Highly Scalable SARS-CoV-2 RNA Detection in Minutes (Talis Biomedical Corporation)
Agency: National Institute of Biomedical Imaging and Bioengineering (NIBIB) / National Institutes of Health
(NIH)
1. Background
The National Institute of Biomedical Imaging and Bioengineering (NIBIB) has an open solicitation for
proposals to provide up to $500 million across multiple projects to rapidly produce innovative SARS-CoV-2
diagnostic tests that will assist the public’s safe return to normal activities. Rapid Acceleration of Diagnostics
(RADx), is a fast-track technology development program that leverages the National Institutes of Health
(NIH) Point-of-Care Technology Research Network (POCTRN). RADx will support novel solutions that build
the U.S. capacity for SARS-CoV-2 testing up to 100-fold above what is achievable with standard approaches.
RADx is structured to deliver innovative testing strategies to the public as soon as late summer 2020 and is
an accelerated and comprehensive multi-pronged effort by NIH to make SARS-CoV-2 testing readily available
to every American.
2. Purpose and Objectives
NIBIB is providing substantial support to accelerate the development, validation, and commercialization of
innovative point-of-care and home-based tests, as well as improvements to clinical laboratory tests, that
can directly detect SARS-CoV-2, the virus that causes COVID-19. NIBIB will support the full range of product
development including commercialization and product distribution. The ultimate goal of the RADx program
— across multiple projects/contracts — is to make millions of tests per week available to the American public,
particularly those most vulnerable to and/or disproportionately impacted by COVID-19, in the late summer
of 2020, and having even more tests available in time for the 2020-2021 flu season.
To meet the accelerated timelines, RADx has assembled a national network of expert technical, clinical,
manufacturing, and regulatory advisors who will provide individualized assistance for project development
and commercialization. Funding for projects selected for this program will be dependent on successfully
meeting aggressive project milestones. NIBIB will provide financial and in-kind support to accelerate the
entire product life-cycle, from design to market, for projects that meet milestones successfully. To ensure
that innovations are available to the public as quickly as possible, NIH will leverage established partnerships
with federal agencies, such as FDA, CDC, CMS, ASPR/BARDA, the Department of Defense, as well as
commercial and private entities to propel technologies developed by RADx into widespread use.
The RADx program will consider innovations at all stages of readiness to circumvent current limitations to
SARS-CoV-2 testing capacity, including:
— Early stage: transformative innovations based on novel testing strategies that have potential for
major scale up
— Mid stage: technologies using novel testing strategies that have demonstrated capability but need
further validation, regulatory approval, and scale up
— Advanced stage (RADx ATP): modification and optimization of existing SARS-CoV-2 testing
approaches, including clinical laboratory tests, that can dramatically increase testing capacity. Note:
This arm of the RADx program is addressed under a separate Acquisition Plan.
Page 1 of 3
Attachment 1 — Statement of Objectives
Design features might include technical innovations that:
— Improve analytical performance, e.g., sensitivity, specificity, dynamic range, limit of detection,
reliability, accuracy, speed (time to test result) and throughput
— Enhance operational performance through, e.g., development of a patient- and user-friendly design,
use of alternative sampling strategies (e.g., saliva, exhaled breath), integration with mobile-devices,
designs for home-based use or strategies to overcome bottlenecks with current testing approaches
— Improve access and reduce the cost of testing.
Scope
RADx-Tech is a two phase program. All applications undergo an intensive week-long risk assessment by a
panel of expert technical, clinical, manufacturing, and regulatory advisors. If the proposed technology meets
viability metrics, projects may be selected to enter phase one.
Phase one, performed under a separate funding mechanism, consists of an accelerated research and
development program in which the awardee receives both financial support and in-kind services through
RADx grant funding. This outcome of this work is a fully instantiated technology ready for clinical validation,
regulatory authorization, production and commercialization.
Phase two, or Work Package 2, of the program, executed under this contract, includes completing the
validation, approval, and production processes in order to deliver a viable product in a scaled up capacity to
the U.S. public.
4,
A.
Performance Objectives (Required Results)
Contract recipients have completed major research and development efforts and are focused in phase
two on completion of required clinical validation, preparation of regulatory submissions, scale-up of
production capabilities, and preparation for full commercialization of their product — a testing
technology. Every contract will encompass similar expectations and milestones concerned with:
1. meeting regulatory requirements, resulting in regulatory authorization for sale and use of the test;
2. instantiation of agreed-upon production capacity;
3. meeting agreed-upon production goals; and
4. implementation of an agreed-upon commercial strategy to bring the test to market in a timeframe
that will impact the COVID-19 pandemic as soon as possible.
Contract funding in phase two is structured in order to reduce risk to the Government, and is dependent
on achievement of specific milestones in the Schedule of Deliverables, according to the Payment
Schedule.
The contractor must use a SARS-Cov-2 test with FDA Emergency Use Authorization (EUA) (or will have
EUA near the time of award), indicating a combination of sensitivity, specificity, and usability
appropriate to the intended use according to FDA and/or CDC guidance, as applicable.
The contractor must make the product available for independent regulatory/validation assessment. The
independent assessor will be selected by the Government.
Page 2 of 3
Attachment 1 — Statement of Objectives
5. Contract Type
The contract type is Firm Fixed Price.
6. Place of Performance
The place of performance will be at the contractor's site.
7. Period of Performance
The period of performance of the contract is anticipated to be July 30, 2020 through July 29, 2021.
8. Deliverables/Delivery Schedule
See the attached Schedule of Deliverables.
9. Other Requirements
A. The contractor must meet regularly (at least weekly) with NIH officials to update on progress toward
deliverables; anticipated and ongoing issues and problems; and timelines for deliverable completion.
When guided by NIH officials, the contractor must be willing to collaborate and cooperate with external
organizations as needed to meet the contract goals in a manner which will not infringe contractor
commercial or intellectual property rights.
10. Appendices
Appendix 1 — Schedule of Deliverables
Page 3 of 3
SCHEDULE OF DELIVERABLES
Deli if
No. Objective Defined Milestone Defined Deliverable Success Criteria peed Stage
All manufacturing and
automation partners identified, | Manufacturing contracts
1 Manufacturing plan | Manufacturing plan and contracts completed. completed 10-Aug-20 4:
Finalize Finalize product design; ready
2 specifications for formal design verification Final product embodiment Design freeze 10-Aug-20 1
Formal design verification
process required for FDA
3 Design verification Design verification submission complete Design verification complete 1-Sep-20 2
Two instruments shipped to
Analytical data in support of Emory CORE for independent
4 Analytical data EUA submission complete Ready for testing at Emory assessment 1-Sep-20 2
Initiate clinical study in support First test performed at clinical
5 Clinical study Clinical study of EUA submission study site 1-Sep-20 2
EUA testing complete and
6 EUA submission EUA submission Completed clinical study package submitted 23-Sep-20 3
Build and Validate
First Cartridge Manufacturing automation Automated manufacturing line Construction of first automated
7 Manufacturing Line | lines design and build begun designs manufacturing line underway 23-Sep-20 3
Instrument Test and validate instrument
8 Inventory inventory Validated instruments Validate initial instruments 23-Sep-20 3
Build and Validate
First Cartridge Automated manufacture of Production capacity of 330,000
9 Manufacturing Line | Validation of first line cartridges cartridges per month 30-Nov-20 4
FDA authorization for the EUA-authorized SARS-CoV-2 viral
10 FDA Approval EUA granted proposed test RNA test 30-Nov-20 4
Instruments and cartridges
11 | Product Launch Product Launch Successful product launch available for sale 30-Nov-20 4
Production scale-up, Validate Second and Third Mfg Production capacity of 1,000,000
12 | cartridges Production scale-up, cartridges | Lines cartridges per month 31-Dec-20 5
3,300 instruments manufactured
Production scale-up, | Production scale-up, Validate instrument production | and available for sale, or already
13 | instrument instrument capacity sold 31-Dec-20 5
SCHEDULE OF DELIVERABLES
Risk mitigation plan
for each identified
risk and update NIH
in a timely manner
of any changes or
newly identified Timely reporting of identified Updated as
14 | risks. All stages. Risk Mitigation Plan risks to the Government. needed. 1-5
Progress report with
supporting
documentation of Updated
scale-up efforts Timely reporting of progress throughout
15 | executed. All stages. Progress Report made for each stage. each stage. 1-5
PAYMENT SCHEDULE
Stage Title Completion Date Firm Fixed Price
¥ Initiate Manufacturing Scale-Up 10-Aug-20 mx)
2 Design Verification 1-Sep-20
3 EUA Submission 23-Sep-20
4 Build and Validate First Cartridge Manufacturing Line 30-Nov-20
5 Validate Second and Third Manufacturing Line 31-Dec-20
Total FFP $ 25,400,000
Amount
SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS
OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30
7” REQUISITION NUMBER PAGE OF
5765387 1 22
2 CONTRACT NO, 3, AWARD’ Js. ORDER NUMBER 5. SOLICITATION NUMBER js. SOLICITATION
75N92020C00011 EFFECTIVE DATE ISSUE DATE
7. FOR SOLICITATION fa. NAME jp TELEPHONE NUMBER (No colect call) JB. OFFER DUE DATE/LOCAL TINE
INFORMATION CALL:
‘9, ISSUED BY ‘cove [TO-NHLBI 10. THISACQUISITIONIS UNRESTRICTED OR SET ASIDE: % FOR:
, . WOMEN-OWNED SMALL BUSINESS
National Institutes of Health SMALL BUSINESS mvoaa) GliceLs Urpor Tre WOMGICONNGD
National Heart, Lung, and Blood HUBZONE SMALL SMAI RIISINFSS PROGRAM aes
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‘SMALL BUSINESS
Wi, DELIVERY FOR FOB DESTINA. [}2. DISCOUNT TERMS 3b, RATING
TION UNLESS BLOCK IS 13a, THIS CONTRACT ISA
MARKED RATED ORDER UNDER
4. METHOD OF SOLICITATION
X| SEE SCHEDULE OPAS IS CEE 700). RFQ FB RFP
75. DELIVERTO CO |TDP, BTHOFF [6 ADMINISTERED BY ‘CODE [ADM-NHLBI
TDP, BTHOFF National Institutes of Health
2 Democracy Plaza, National Heart, Lung and Blood
6707 Democracy Blvd Institute
Bethesda MD 20817 Bethesda MD 20892-7511
Tas CONTRAGTOR: cove 1081179621 moun 18a. PAYMENT WILL BE MADE BY Coe IWHLBI INV-BR-B
Mammoth Biosciences, Inc. NHLBI Branch B Invoice
279 EB Grand Ave Ste 400 2115 East Jefferson St, MSC 8500
South San Francisco CA 940804804
‘TELEPHONE NO,
Room 4B-432
Bethesda MD 20892-8500
170, CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER
/18b. SUBMIT INVOIGES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW
IS CHECKED ‘SEE ADDENDUM
19,
ITEM NO,
20.
‘SCHEDULE OF SUPPLIESISERVICES
2
‘QUANTITY
2.
unit
23,
UNIT PRICE
24,
AMOUNT
TITLE: RADx Tech
Platform
Period of Performance:
1 IRADx Tech Project #2324 Mammoth - Stage 1 -
Supply Vendor Agreements
Continued ...
(Use Reverse and/or Attach Additional Sheets as Necessary)
25. ACCOUNTING AND APPROPRIATION DATA
See schedule
Mammoth Biosciences Detection
lof SARS-CoV-2 with the CRISPR-based DETECTR™
07/30/2020 to 07/29/2021
TOTAL AWARD AMOUNT (For Govt. Use Only)
$9,150,000.00
27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, §2.212-4. FAR 52.212-3 AND 52.212-5 AREATTACHED. ADDENDA ARE (ARE NOT ATTACHED.
27. CONTRACTIPURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE [| ARE NOT ATTACHED.
28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN 29. AWARD OF CONTRACT: OFFER
COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER
ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL
SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.
DATED YOUR OFFER ON SOLICITATION (BLOCK 5),
INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH
HEREIN, IS ACCEPTED AS TO ITEMS:
‘30a, SIGNATURE OF OFFERORIGONTRAGTOR
fener
‘Bia. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)
Kristiane E. Cooper -S Digitally signed by Kristiane E. Cooper -S
[30c. DATE SIGNED
July 29, 2020
305. NAME AND TITLE OF SIGNER (Type or print)
Janice Chen, CTO
Date: 2020.07.30 13:30:32 -04'00°
[31b. NAME OF CONTRACTING OFFICER (Type or print) [31c. DATE SIGNED
IKristiane E. Cooper
AUTHORIZED FOR LOCAL REPRODUCTION
PREVIOUS EDITION IS NOT USABLE
‘STANDARD FORM 1449 (REV. 2/2012)
Prescribed by GSA - FAR (48 CFR) 53.212
19, 20. 2 2. 23. 24
ITEM NO, ‘SCHEDULE OF SUPPLIESISERVICES ‘quantity | UNIT UNIT PRICE AMOUNT
Project Data:
151201-2020.300.COVID-19.DIAG-HN81 NIBIB OD
OFFICE OF THE DIRECTOR-25235 ALL OTHER SERVICES
(NON-FEDERAL SOURCES) -07/29/2020
Accounting Info:
08039820200DAD-2020-83-8100-EM81000000C-E-C4 400-40
6-COVD-25235-9999-9999-9999-151201-2020.300.COVID-|
19.DIAG-HN81 NIBIB OD OFFICE OF THE
DIRECTOR-07/29/2020-25235 ALL OTHER SERVICES
(NON-FEDERAL SOURCES) -8045207
Funded
FOB: Destination
2 RADx Tech Project #2324 Mammoth - Stage 2 -
Manufacturing Design Transfer Instruments
Project Data:
151201-2020.300.COVID-19.DIAG-HN81 NIBIB OD
OFFICE OF THE DIRECTOR-25235 ALL OTHER SERVICES
(NON-FEDERAL SOURCES) -07/29/2020
Accounting Info:
08039820200DAD-2020-83-8100-EM81000000C-E-C4 400-40
6-COVD-25235-9999-9999-9999-151201-2020.300.COVID-
19.DIAG-HN81 NIBIB OD OFFICE OF THE
DIRECTOR-07/29/2020-25235 ALL OTHER SERVICES
Continued ...
32a, QUANTITY IN COLUMN 21 HAS BEEN
RECEIVED INSPECTED ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:
32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32c. DATE 3;
RINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE
32e, MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE
32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE
33. SHIP NUMBER [35. AMOUNT VERIFIED 36. PAYMENT
CORRECT FOR
39. SIR VOUCHER NUMBER
41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT.
41b, SIGNATURE AND TITLE OF CERTIFYING OFFICER
37. CHECK NUMBER
COMPLETE
PARTIAL
PARTIAL FINAL
38, SIR ACCOUNT NUMBER 40. PAID BY
|42a. RECEIVED BY (Print)
1c. DATE
42b. RECEIVED AT (Location)
|42c. DATE REC'D (YY/MM/DD)
42d, TOTAL CONTAINERS
‘STANDARD FORM 1449 (REV. 2/2012) BACK
FERENCE NO. OF DOCUMENT BEING CONTINUED
CONTINUATION SHEET 15N92020C00011
NAME OF OFFEROR OR CONTRACTOR
Mammoth Biosciences, Inc.
ITEM NO, ‘SUPPLIESISERVICES QUANTITY UNIT UNIT PRICE AMOUNT
(A) (B) (c) — (D) (E) (F)
(NON-FEDERAL SOURCES) -8045207
Funded: [ox
FOB: Destination
3 RADx Tech Project #2324 Mammoth - Stage 3 - Re
Manufacturing Design - Reagents
Project Data:
151201-2020.300.COVID-19.DIAG-HN81 NIBIB OD
OFFICE OF THE DIRECTOR-25235 ALL OTHER SERVICES
(NON-FEDERAL SOURCES) -07/29/2020
Accounting Info:
08039820200DAD-2020-83-8100-EM81000000C-E-C4400-40
6-COVD-25235-9999-9999-9999-151201-2020. 300. COVID-
19.DIAG-HN81 NIBIB OD OFFICE OF THE
DIRECTOR-07/29/2020-25235 ALL OTHER SERVICES
(NON-FEDERAL SOURCES) -8045207
NSN 7540-01-152-8067 ‘OPTIONAL FORM 336 (4-86)
‘Sponsored by GSA
FAR (48 CFR) 53.110
PART | — THE SCHEDULE
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
ARTICLE B.1. BRIEF DESCRIPTION OF SERVICES
This Letter Contract formsa preliminary understanding between Mammoth Biosciences and the National
Institutes of Health (NIH) and is issued asa result of the Rapid Acceleration of Diagnostics (RADx) to increase
the testing capacity of high throughput labs by scaling up late stage testing platforms for detecting SARS-
CoV-2, the virus that causes COVID-19. Issuance of this Letter Contract authorizes the Contractor to immediately
begin the activities necessary to perform the requirements as identified in the Statement of Objectives covering
the full range of activities needed to increase capacity and optimize throughput necessary to distribute a viable
product to the public.
The scope of work executed under this contract, includes completing the validation, approval, and production
processes in order to deliver a viable product in a scaled up capacity to the U.S. public. Mammoth Biosciences
technology to support this effort is Detection of SARS-CoV-2 with the CRISPR-based DETECTR™ platform
This Letter Contract has been issued based on the application and preliminary work filesubmitted by the
contractor and subsequent documentation submitted during the Point of Care Technology Research Networ
(POCTRN) application review process. The Contractor's inability to meet the requirements as defined within this
Letter Contract and proposed within the POCTRN application process may result in the termination of the Letter
Contract in accordance with the termination clauses contained herein.
ARTICLE B.2. PRICES
The total Firm Fixed Price (FFP) amount for this Letter Contract is $9,150,000.
Milestone Payment schedule
Stage Amount
1 Report to NIH documenting supply and vendor agreements
Milestone 1.17 Dray
im
Milestone 1.2:[
Milestone 1.3:
yay
2 Report to NIH summarizing approved instrument specifications.
Milestone 2.1:[°
DNA
Milestone 2.2)
pe ]
Contract No. 75N92020C00011 Page 4
Milestone 23f bya)
ie
3 Report to NIH summarizing approved reagent specifications
Milestone 3.1 |
oa
Milestone 3.29 |
(py(4)
Total Letter contract milestone payments $9,150,000
ARTICLE B.3. ADVANCE UNDERSTANDINGS
a. The parties acknowledge and agree that the situation around COVID-19 is highly dynamic, evolving
rapidly, and subject to significant uncertainty. The Letter Contract is being executed on an expedited
timeline to meet an urgent and compelling government need without the benefit of prior negotiation.
Thus, the parties will negotiate in good faith to ensure that the definitized contract reflects an
appropriate allocation of risk and responsibility and that it is consistent with the application and
preliminary work file submitted by the contractor and subsequent documentation submitted during the
application review process and the discussions between the parties that have taken place between date
of application submission through Letter Contract issuance. Until the Performance Work Statement
(PWS) is finalized the Statement of Objective (SOO) will govern.
b. The parties anticipate that the definitive contract resulting from this Letter Contract will include a
negotiated firm fixed price not to exceed $23,081,269 (see Attachment 2).
c. Funding in the amount not to exceed $9,150,000 is made available under this letter contract. The
contractor shall not incur costs in excess of this amount
d. Commercial Item Status: The services provided by the Contractor under the Letter Contract and any
definitized contract constitute commercial item services, and the terms of any definitized contract will
reflect that understanding.
e. Performance Work Statement: The parties will negotiate the Performance Work Statement in the
process of contract definitization to fairly reflect the application and preliminary work file submitted by
the contractor and subsequent documentation submitted during the application review process and the
discussions between the parties that have taken place between application submission through letter
contract issuance.
f. HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to
include rating this order in accordance with 45 CFR Part 101, Subpart A—Health Resources Priorities and
Allocations System.
g. The parties agree prior to negotiate further the terms of milestone payments to include in the
definitized contract. In the negotiation, the parties will consider terms addressing liquidation of
milestone payments.
Contract No. 75N92020C00011 Page 5
h. Successful performance under this contract requires the Contractor obtain and maintain an Emergency
Use Authorization (EUA) from the Food and Drug Administration (FDA); the Contractor shall copy us on
all FDA correspondence related to the project, including email communications to and from the FDA.
The FDA EUA services provided under this Letter Contract constitute a commercial service to detect
SARS-CoV-2.
i, Fair Pricing: The Rapid Acceleration of Diagnostics (RADx) application review process determined the
cost per test is competitive with the current market price. The Contractor must comply with applicable
federal law to ensure that prices to consumers are offered at fair market rate and at a rate consistent
with the objective to increase and improve testing in the United States.
j. In accordance with the goals of the RADx program, the testing capabilities produced under this contract
are to to be for utilization within the U.S. and its territories.
k. Sharing Data and Reports: The Contractor will be required to provide data and reports (e.g.,
manufacturing, supply chain, production rates), which NIH will use to evaluate completion or
achievement of milestones, progress toward deliverables, and compliance with the requirements of this
Letter Contract. NIH may use the data to coordinate with other U.S. Government Agencies to accelerate
development and deployment of innovative COVID-19 diagnostic tests, and ensure effective stewardship
of federal funds. Sharing data within the federal government enables NIH to discuss the project’s
challenges and progress with federal agencies offering scientific, manufacturing, and logistics expertise.
To ensure that innovations are available to the public as quickly as possible, NIH will leverage
established partnerships with federal agencies, such as FDA, CDC, CMS, ASPR/BARDA, and the
Department of Defense, and partnerships with State agencies to propel technologies developed by RADx
into widespread use.
|. Contractor Facilities: The contractor shall certify that they will maintain their Facility and Equipment in
satisfactory operating condition, as required to enable the contractor to perform the deliverables and
achieve the milestones in accordance with the Statement of Objectives and all other applicable laws,
regulations, rules or orders. Routine repairs, preventive maintenance, and service contracts for the
Facility and Equipment shall be arranged by contractor at no additional cost to the Government.
m. FAR 52.212-4 (I) Termination for the Government’s convenience. The Government reserves the right to
terminate this contract, or any part hereof, for its sole convenience. In the event of such termination,
the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its
suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be
paid a percentage of the contract price reflecting the percentage of the work performed prior to the
notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the
Government using its standard record keeping system, have resulted from the termination. The
Contractor shall not be required to comply with the cost accounting standards or contract cost principles
for this purpose. This paragraph does not give the Government any right to audit the Contractor's
records. The Contractor shall not be paid for any work performed or costs incurred which reasonably
could have been avoided.
n. Letter Contract Termination: In accordance with FAR 52.212-4(m), the Government may terminate this
contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor
Contract No. 75N92020C00011 Page 6
fails to comply with any contract terms and conditions, or fails to provide the Government, upon
request, with adequate assurances of future performance. In the event of termination for cause, the
Government shall not be liable to the Contractor for any amount for supplies or services not accepted,
and the Contractor shall be liable to the Government for any and all rights and remedies provided by
law. If it is determined that the Government improperly terminated this contract for default, such
termination shall be deemed a termination for convenience.
o. Security and Privacy of Protected Health Information (PHI) processed under this contract: The
Contractor , shall meet the definition of either a Covered Entity or Business Associate under the Health
Insurance Portability and Accountability Act of 1996 (HIPAA). The contractor shall therefore comply
with the HIPAA regulatory standards set forth in the Code of Federal Regulations (CFR) 45 C.F.R. Part
160, Part 162, and Part 164. To the extent that the Contractor engages subcontractors or other Business
Associates to provide services under this Contract, and such Subcontractors or Business Associates will
receive or create protected health information (PHI) on behalf of the contractor, the contractor shall
obtain satisfactory assurances from its business associate that the business associate will appropriately
safeguard the protected health information. The satisfactory assurances must be in writing, whether in
the form of a contract or other agreement between the Contractor and the business associate. In the
event of a suspected or known security or privacy breach, in addition to following the procedures set
forth in 45 C.F.R. Part 164, the contractor shall also immediately notify the NIH via the Contracting
Officer (CO) and the Contracting Officer’s Representative (COR).
p. Parties agree to establish critieria for milestones during contract definitization where applicable.
q. Security and Privacy of Protected Health Information (PHI) processed under this contract: The
Contractor shall meet the definition of either a Covered Entity or Business Associate under the Health
Insurance Portability and Accountability Act of 1996 (HIPAA). The contractor shall therefore comply with
the HIPAA regulatory standards set forth in the Code of Federal Regulations (CFR) 45 C.F.R. Part 160,
Part 162, and Part 164. To the extent that the Contractor engages subcontractors or other Business
Associates to provide services under this Contract, and such Subcontractors or Business Associates will
receive or create protected health information (PHI) on behalf of the contractor, the contractor shall
obtain satisfactory assurances from its business associate that the business associate will appropriately
safeguard the protected health information. The satisfactory assurances must be in writing, whether in
the form of a contract or other agreement between the Contractor and the business associate. In the
event of a suspected or known security or privacy breach, in addition to following the procedures set
forth in 45 C.F.R. Part 164, the contractor shall also immediately notify the NIH via the Contracting
Officer (CO) and the Contracting Officer’s Representative (COR).
r. The parties agree to address HHS Information Security and Privacy Requirements, as applicable, during
definitization of the contract.
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
ARTICLE C.1, STATEMENT OF OBJECTIVES
Independently and not as an agent of the Government, the Contractor shall furnish all the necessary
Contract No. 75N92020C00011 Page 7
services, qualified personnel, material, equipment, and facilities, not otherwise provided by the
Government as needed to perform the Statement of Objectives, dated July 27, 2020, set forth in SECTION
J—List of Attachments, attached hereto and made a part of this Letter Contract. Work to be performed
shall be consistent with the application and preliminary work file submitted by the Contractor and
subsequent documentation submitted during the application review process and the discussions between
the parties that have taken place between date of application submission through Letter Contract
issuance.
ARTICLE C.2. REPORTING REQUIREMENTS
All reports required herein shall be submitted in electronic format only. All electronic reports submitted shall be
compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents
for Section 508 compliance, including guidance and specific checklists, by application, can be found at:
http://www. hhs.gov/web/508/index.htm! under "Making Files Accessible."
Reporting requirements TBD.
Placeholder: De-identified data for NIH research database
SECTION D — PACKAGING, MARKING, AND SHIPPING
There are no additional instructions or specifications applicable to this contract other than the delivery
instructions contained herein.
SECTION E - INSPECTION AND ACCEPTANCE
a. The Contracting Officer or the duly authorized Contracting Officer's Representative (COR) will perform
inspection and acceptance of deliverables to be performed and the milestones to be achieved.
b. Inspection and acceptance will be performed as identified in the contract requirements.
SECTION F - DELIVERIES OR PERFORMANCE
ARTICLE F.1. PERIOD OF PERFORMANCE
The period of performance of the contract is anticipated to be July 30, 2020 through July 29, 2021.
ARTICLE F.2. DELIVERIES
Satisfactory performance shall be deemed to occur upon performance of the work described in the Statement of
Objectives Article in SECTION C of this Letter Contract and upon notice and acceptance by the Contracting
Officer, or the duly authorized representative, in accordance with the stated deliverables schedule.
The deliverables or documentation thereof shall be submitted to the Contracting Officer or designated
Contracting Officer Representative (COR).
SECTION G - CONTRACT ADMINISTRATION DATA
ARTICLE G.1. CONTRACTING OFFICER (CO)
The following Contracting Officer (CO) will represent the Government for the purpose of
Contract No. 75N92020C00011 Page 8
this contract:
Name: Kristiane E. Cooper
Telephone: 301-827-7704
Email: kristi.cooper@nih.gov
The Contracting Officer is the only person with authority to act as agent of the Government
under this task order. Only the Contracting Officer has authority to:
1) direct or negotiate any changes in the Satement of Objectives or Performance Work Statement;
2) modify or extend the period of performance;
3) change the deliverables or milestones schedule;
4) authorize reimbursement to the Contractor for any costs incurred during the performance of this
Letter Contract;
5) otherwise change any terms and conditions of this Letter Contract; or
6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in
Section K of this Letter Contract.
All correspondence (including invoices) that proposes or otherwise involves waivers, deviations, or modifications
to requirement shall be provided to the CO issuing this Letter Contract and the COR supporting the CO.
ARTICLE G.2. CONTRACTING OFFICER'S REPRESENTATIVE (COR)
The following Contracting Officer's Representative (COR) is anticipated to represent the Government for
the purpose of this contract:
Christopher Hartshorn, PhD
Telephone: 240-781-3315
Email: christoper.hartshorn@nih.gov
The COR is responsible for:
(1) monitoring the Contractor's technical progress, including the surveillance and assessment of
performance and recommending to the Contracting Officer changes in requirements;
(2) interpreting the Statement of Objectives and any other technical performance requirements;
(3) performing technical evaluation as required;
(4) performing technical inspections and acceptances required by this Letter Contract; and
(5) assisting in the resolution of technical problems encountered during performance.
The Government may unilaterally change the COR designation.
ARTICLE G.3. PRIMARY PROGRAM MANAGER
The Primary Program Manager specified in this task order is considered to be essential to work
performance. At least 30 days prior to any changes to the individual listed below to other programs or task
orders (or as soon as reasonably possible, if an individual must be replaced, for example, as a result of
leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit
comprehensive justification for the change request (including proposed substitutions for primary program
manager) to permit evaluation by the Government of the impact on performance under this task order.
The Contractor shall not replace any primary program manager without the written consent of the
Contracting Officer. The Government may modify the task order to add or delete primary program
manager at the request of the contractor or Government. In no case shall the individual’s effort exceed
Contract No. 75N92020C00011 Page 9
100% across all task orders.
Primary Program Manager
ARTICLE G.4. INVOICE SUBMISSION
In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include
the following information on the face page of all task order payment requests:
a. The Contract Title is: RADx Tech Project No. 2324 - Mammoth - Detection of SARS-CoV-2 with the
CRISPR-based DETECTR™ platform
b. The Contract Line Items are defined within the Section 20. Schedule of Supplies/Services of the Standard
Form 1449.
c. Invoice Instructions are attached and made part of this Letter Contract. The Contractor shall follow the
attached instructions and submission procedures specified below to meet the requirements of a "proper
invoice" pursuant to FAR Subpart 32.9, Prompt Payment.
1. Payment requests shall be submitted to the offices identified below. Do not submit supporting
documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your payment request unless
specified elsewhere in this Letter Contract or requested by the Contracting Officer.
a. One copy of the invoice shall be submitted to the approving official at the following email
addresses:
NHLBI Branch B Central Mailbox (NHLBIContractsBranchB@mail.nih.gov)
NIH centralized invoice email box: invoicing@nih.gov
2. E-Mail: The Contractor shall submit an electronic copy of the payment request to the approving official
instead of a paper copy. The payment request shall be transmitted as an attachment via e-mail to the
address listed above in one of the following formats: MSWord, MS Excel, or Adobe Portable
Document Format (PDF). Only one payment request shall be submitted per e-mail and the subject line
of the e-mail shall include the Contractor's name, contract number, and unique invoice number.
3. In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall
include the following information on the face page of all payment requests (invoices):
a. Name of the Office of Acquisitions. The Office of Acquisitions for this task order is NHLBI.
b. Central Point of Distribution. For the purpose of this Task Order, the Central Point of Distribution
is NHLBI Branch B Invoices.
c. Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall
identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number
that appears after the Contractor's name on the face page of the contract. [Note: A VIN is
assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to
include the VIN number.] _\f the Contractor has neither a TIN, DUNS, or VIN, contact the
Contracting Officer.
d. DUNS or DUNS+4 Number. The DUNS number must identify the Contractor's name and address
exactly as stated in the contract and as registered in the Central Contractor Registration (CCR)
database. If the Contractor does not have a valid DUNS number, it shall identify the Vendor
Contract No. 75N92020C00011 Page 10
Identification Number (VIN) on the payment request. The VIN is the number that appears after
the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts
awarded on or after June 4, 2007, and any existing contract modified to include the VIN
number.] \f the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.
e. Invoice Matching Option. This Letter Contract requires a two-way match.
f. Unique Invoice Number. Each payment request must be identified by a unique invoice number,
which can only be used one time regardless of the number of contracts or orders held by an
organization.
g. PRISM/NBS Line Item Number and associated PRISM/NBS Line Item Period of Performance (see
Section B — PRICES/OPTION).
d. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-6088.
SECTION H - ADDITONAL CONTRACT CLAUSES
ARTICLE H.1. SUBCONTRACTING PROVISIONS
The parties agree to address the requirements of this Article during definitization of the contract.
a. Small Business Subcontracting Plan
1. The Small Business Subcontracting Plan, dated. is attached hereto and made a
part of this Letter Contract.
2. The failure of any Contractor or subcontractor to comply in good faith with FAR Clause 52.219-8,
entitled "Utilization of Small Business Concerns" incorporated in this Letter Contract and the
attached Subcontracting Plan, will be a material breach of such contract or subcontract and
subject to the remedies reserved to the Government under FAR Clause 52.219-16 entitled,
"Liquidated Damages-Subcontracting Plan."
b. Subcontracting Reports
The Contractor shall submit the following Subcontracting reports electronically via the "electronic
Subcontracting Reporting System (eSRS) at http://www.esrs.gov.
1. Individual Subcontract Reports (ISR)
Regardless of the effective date of this contract, the Report shall be due on the following
dates for the entire life of this contract:
April 30th October 30th
Expiration Date of Contract
Summary Subcontract Report (SSR)
2. Regardless of the effective date of this contract, the Summary Subcontract Report shall be
submitted annually on the following date for the entire life of this contract:
October 30th
For both the Individual and Summary Subcontract Reports, the Contracting Officer shall be included
Contract No. 75N92020C00011 Page 11
as a contact for notification purposes at the following e-mail address:
Kristiane E. Cooper — kristi.cooper@nih.gov
Contracting Officer
ARTICLE H.2. CONFIDENTIALITY OF INFORMATION
a. Confidential information, as used in this article, means information or data of a personal
nature about an individual, or proprietary information or data submitted by or pertaining
to an institution or organization.
b. The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this
Letter Contract specific information and/or categories of information which the Government will
furnish to the Contractor or that the Contractor is expected to generate which is confidential.
Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such
confidential information from time to time during the performance of the Letter Contract.
Failure to agree will be settled pursuant to the "Disputes" clause.
c. If itis established elsewhere in this Letter Contract that information to be utilized under this
contract, or a portion thereof, is subject to the Privacy Act, the Contractor will follow the rules
and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing
regulations and policies, with respect to systems of records determined to be subject to the
Privacy Act.
d. Confidential information, as defined in paragraph (a) of this article, shall not be disclosed without
the prior written consent of the individual, institution, or organization.
e. Whenever the Contractor is uncertain with regard to the proper handling of material under the
contract, or if the material in question is subject to the Privacy Act or is confidential information
subject to the provisions of this article, the Contractor should obtain a written determination
from the Contracting Officer prior to any release, disclosure, dissemination, or publication.
f. Contracting Officer determinations will reflect the result of internal coordination with
appropriate program and legal officials.
g. The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping
provisions in other Federal, State or local laws.
ARTICLE H.3. PUBLICATION AND PUBLICITY
In addition to the requirements set forth in HHSAR Clause 352.227-70, Publications and Publicity
incorporated by reference in SECTION | of this contract, the Contractor shall acknowledge the
support of the National Institutes of Health whenever publicizing the work under this Letter
Contract in any media by including an acknowledgment substantially as follows:
"This project has been funded in whole or in part with Federal funds from the National Institutes
of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health
Contract No. 75N92020C00011 Page 12
and Human Services, under Contract No. 75N92020C00011.
ARTICLE H.4. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE
Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in
NIH funded programs is encouraged to report such matters to the HHS Inspector General's Office
in writing or on the Inspector General's Hotline. The toll free number is 1-800-HHS-TIPS (1-800-
447-8477). All telephone calls will be handled confidentially. The website to file a complaint on-
line is: http://oig.hhs.gov/fraud/hotline/ and the mailing address is:
US Department of Health and Human Services Office of Inspector
General
ATTN: OIG HOTLINE OPERATIONS
P.O. Box 23489 Washington, D.C. 20026
PART II - CONTRACT CLAUSES
SECTION | - CONTRACT CLAUSES
ARTICLE 1.1. ADDITIONAL CONTRACT CLAUSES
The parties agree to address the requirements of this Article during definitization of the contract.
This contract incorporates the following clauses by reference, (unless otherwise noted), with the same force and
effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.
a
b.
Cc
d
sR +O
ypreposagtT
FAR Clause 52.212-3 Offeror Representations and Certifications - Commercial Items (May 2014)
FAR Clause 52.212-4 Contract Terms and Conditions —- Commercial Items (Oct 2018)
FAR Clause 52.203-13, Contractor Code of Business Ethics and Conduct (October 2015)
FAR Clause 52.204-2, Security Requirements (August 1996).
1. Alternate | (April 1984) is not applicable to this contract.
2. Alternate II (April 1984) is not applicable to this contract.
FAR Clause 52.204-9, Personal Identity Verification of Contractor Personnel (January 2011).
FAR Clause 52.204-13, System for Award Management Maintenance
FAR Clause 52.204-18 Commercial and Government Entity Code Maintenance (July 2016)
FAR Clause 52.204-23 Prohibition on Contracting for Hardware, Software, and Services Developed or
Provided by Kaspersky Lab and Other Covered Entities
FAR Clause 52.209-10, Prohibition on Contracting With Inverted Domestic Corporations(November
2015).
FAR Clause 52.222-4, Contract Work Hours and Safety Standards - Overtime Compensation -General
(May 2014).
FAR Clause 52.222-29, Notification of Visa Denial (April 2015).
FAR Clause 52.223-15, Energy Efficiency in Energy-Consuming Products (December 2007).
. FAR Clause 52.224-1, Privacy Act Notification (April 1984).
FAR Clause 52.224-2, Privacy Act (April 1984).
FAR Clause 52.227-1, Authorization and Consent (June 2007)
FAR Clause 52.227-3, Patent Indemnity (APR 1984)
FAR Clause 52.227-11, Patent Rights —- Ownership by the Contractor (May 2014)
FAR Clause 52.227-14, Rights in Data - General (May 2014).
FAR Clause 52.227-14, Rights in Data - General (May 2014) Alternate II (Dec 2007).
Contract No. 75N92020C00011 Page 13
t. FAR Clause 52.232-40, Providing Accelerated Payments to Small Business Subcontractors
ARTICLE 1.2. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT
a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES
Additional clauses other than those listed below which are based on the type of contract/Contractor
shall be determined during negotiations. This contract incorporates the following clauses in full text.
1. FAR 52.216-23 - EXECUTION AND COMMENCMENT OF WORK (APR 1984)
The Contractor shall indicate acceptance of this letter contract by signing One Copy of this Letter
Contract and returning them to the Contracting Officer not later than July 29, 5:00 EST. Upon
acceptance by both parties, the Contractor shall proceed with performance of the work, including
purchase of necessary materials.
2. FAR 52.216-24 - LIMITATION OF GOVERNMENT LIABILITY (APR 1984)
(a) In performing this Letter Contract, the Contractor is not authorized to make expenditures or incur
obligations exceeding $9,150,000 dollars.
(b) The maximum amount for which the Government shall be liable if this Letter Contract is
terminated is $9,150,000 dollars.
3. FAR 52.216-25 - CONTRACT DEFINITIZATION (OCT 2010)
(a) A Firm Fixed Price (FFP) definitive contract is contemplated. The Contractor agrees to begin promptly
negotiating with the Contracting Officer the terms of a definitive contract that will include (1) all clauses
required by the Federal Acquisition Regulation (FAR) on the date of execution of the letter contract, (2) all
clauses required by law on the date of execution of the definitive contract, and (3) any other mutually
agreeable clauses, terms, and conditions. The Contractor agrees to submit a Firm Fixed Price proposal,
including data other than certified cost or pricing data, and certified cost or pricing data, in accordance with
FAR 15.408, Table 15-2, supporting its proposal.
(b) Date for submission of the price proposal, required pricing data and data other than certified cost
or pricing data, and if required, make-or-buy and subcontracting plans:
Date for start of negotiations: 08/17/2020
Target date for definitization: 09/15/2020 or sooner
Definitization Schedule Date
Statement of Objectives Review 07/26/2020
Issuance of Letter Contract 07/30/2020
Letter Contract Post Award Kick Off meeting 07/31/2020
Contractor Technical and Revised Price 08/10/2020
Proposal Submittal
Request Other than certified cost or pricing 08/17/2020
data
Project Officer’s Technical 8/14/2020
Questionnaire/Technical Evaluation &Review
Contract No. 75N92020C00011 Page 14
Negotiations Start 08/17/2020
Definitization of Letter Contract 09/15/2020
(c) If agreement on a definitive contract to supersede this letter contract is not reached by the target
date in paragraph (b) of this section, or within any extension of it granted by the Contracting
Officer, the Contracting Officer may, with the approval of the head of the contracting activity,
determine a reasonable price or fee in accordance with subpart 15.4 and part 31 of the FAR,
subject to Contractor appeal as provided in the Disputes clause. In any event, the Contractor shall
proceed with completion of this Letter Contract, subject only to the Limitation of Government
Liability clause.
(1) After the Contracting Officer’s determination of price or fee, this Letter Contract shallbe
governed by-
(i) All clauses required by the FAR on the date of execution of this Letter Contract for
either fixed-price or cost-reimbursement contracts, as determined by the Contracting
Officer under this paragraph (c);
(ii) All clauses required by law as of the date of the Contracting Officer’s determination;
and
(iii) Any other clauses, terms, and conditions mutually agreed upon.
(2) To the extent consistent with paragraph (c)(1) of this section, all clauses, terms, and
conditions included in this Letter Contract shall continue in effect, except those that by
their nature apply only to a Letter Contract.
4, FAR Clause 52.204-21, Basic Safeguarding of Covered Contractor Information Systems (Jun 2016)
(a) Definitions. As used in this clause—
Covered contractor information system means an information system that is owned or
operated by a contractor that processes, stores, or transmits Federal contract
information.
Federal contract information means information, not intended for public release, that is
provided by or generated for the Government under a contract to develop or deliver a
product or service to the Government, but not including information provided by the
Government to the public (such as on public websites) or simple transactional
information, such as necessary to process payments.
Information means any communication or representation of knowledge such as facts,
data, or opinions, in any medium or form, including textual, numerical, graphic,
cartographic, narrative, or audiovisual (Committee on National Security Systems
Instruction (CNSSI) 4009).
Information system means a discrete set of information resources organized for the
collection, processing, maintenance, use, sharing, dissemination, or disposition of
information (44 U.S.C. 3502).
Safeguarding means measures or controls that are prescribed to protect information
systems.
Contract No. 75N92020C00011 Page 15
(b) Safeguarding requirements and procedures.
(1) The Contractor shall apply the following basic safeguarding requirements and
procedures to protect covered contractor information systems. Requirements and
procedures for basic safeguarding of covered contractor information systems shall
include, at a minimum, the following security controls:
(i) Limit information system access to authorized users, processes acting on behalf of
authorized users, or devices (including other information systems).
(ii) Limit information system access to the types of transactions and functions that
authorized users are permitted to execute.
(iii) Verify and control/limit connections to and use of external information systems.
(iv) Control information posted or processed on publicly accessible information
systems.
(v) Identify information system users, processes acting on behalf of users, or devices.
(vi) Authenticate (or verify) the identities of those users, processes, or devices, as a
prerequisite to allowing access to organizational information systems.
(vii) Sanitize or destroy information system media containing Federal Contract
Information before disposal or release for reuse.
(viii) Limit physical access to organizational information systems, equipment, and the
respective operating environments to authorized individuals.
(ix) Escort visitors and monitor visitor activity; maintain audit logs of physical access;
and control and manage physical access devices.
(x) Monitor, control, and protect organizational communications (i.e., information
transmitted or received by organizational information systems) at the external
boundaries and key internal boundaries of the information systems.
(xi) Implement subnetworks for publicly accessible system components that are
physically or logically separated from internal networks.
(xii) Identify, report, and correct information and information system flaws in a timely
manner.
(xiii) Provide protection from malicious code at appropriate locations within
organizational information systems.
(xiv) Update malicious code protection mechanisms when new releases are available.
(xv) Perform periodic scans of the information system and real-time scans of files from
Contract No. 75N92020C00011 Page 16
external sources as files are downloaded, opened, or executed.
(2) Other requirements. This clause does not relieve the Contractor of any other specific
safeguarding requirements specified by Federal agencies and departments relating to
covered contractor information systems generally or other Federal safeguarding
requirements for controlled unclassified information (CUI) as established by Executive
Order 13556.
(c) Subcontracts. The Contractor shall include the substance of this clause, including this
paragraph (c), in subcontracts under this contract (including subcontracts for the
acquisition of commercial items, other than commercially available off-the-shelf items), in
which the subcontractor may have Federal contract information residing in or transiting
through its information system.
(End of clause)
5, FAR 52.214-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-
Commercial Items (Jul 2020)
(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses,
which are incorporated in this contract by reference, to implement provisions of law or
Executive orders applicable to acquisitions of commercial items:
(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or
Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further
Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in
subsequent appropriations acts (and as extended in continuing resolutions)).
(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or
Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L.
115-91).
(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video
Surveillance Services or Equipment. (Aug 2019) (Section 889(a)(1)(A) of Pub. L. 115-
232).
(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov
2015).
(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).
(6) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and
108-78 ( 19 U.S.C. 3805 note)).
(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting
Officer has indicated as being incorporated in this contract by reference to implement
provisions of law or Executive orders applicable to acquisitions of commercial items:
Selections will be made by the Contracting Officer during definitization.
Contract No. 75N92020C00011 Page 17
___ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (JUNE 2020),
with Alternate | (Oct 1995) ( 41U.S.C.4704 and 10 U.S.C. 2402).
__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509)).
___ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment
Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the
American Recovery and Reinvestment Act of 2009.)
___ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN
2020) (Pub. L. 109-282) ( 31 U.S.C. 6101 note).
___ (5) [Reserved].
__ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section
743 of Div. C).
___(7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery
Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).
___ (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors
Debarred, Suspended, or Proposed for Debarment. (JUN 2020) (31 U.S.C. 6101 note).
___ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (OCT
2018) (41 U.S.C. 2313).
___ (10) [Reserved].
___ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (MAR
2020) (15 U.S.C. 657a).
__ (ii) Alternate | (Mar 2020) of 52.219-3.
___ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business
Concerns (Mar 2020) (if the offeror elects to waive the preference, it shall so indicate in its
offer) (15 U.S.C. 657a).
__ (ii) Alternate | (Mar 2020) of 52.219-4.
___ (13) [Reserved]
___ (14) (i) 52.219-6, Notice of Total Small Business Set-Aside (Mar 2020) of 52.219-
6 (15 U.S.C. 644).
___ (ii) Alternate | (MAR 2020) of 52.219-6 .
___ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (Mar 2020) (15 U.S.C. 644).
__ (ii) Alternate | (Mar 2020) of 52.219-7.
___ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).
___(17) (i) 52.219-9, Small Business Subcontracting Plan (Jun 2020) (15 U.S.C. 637(d)(4)).
__ (ii) Alternate | (Nov 2016) of 52.219-9.
__ (iii) Alternate II (Nov 2016) of 52.219-9.
___(iv)Alternate III (Jun 2020) of 52.219-9.
___ (v)AlteRNATE IV (JUN 2020) OF 52.219-9
___ (18) (i) 52.219-13, Notice of Set-Aside of Orders (Mar 2020) (15 U.S.C. 644(r)).
__ (ii) Alternate | (Mar 2020) of 52.219-13.
___ (19) 52.219-14, Limitations on Subcontracting (Mar 2020) (15 U.S.C. 637(a)(14)).
___ (20) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan
1999) (15 U.S.C. 637(d)(4)(F)(i)).
___(21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Mar
2020) (15 U.S.C. 6574).
___ (22) (i) 52.219-28, Post Award Small Business Program Rerepresentation (May
2020) (15 U.S.C. 632(a)(2)).
__ (ii) Alternate | (MAR 2020) of 52.219-28.
___ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged
Contract No. 75N92020C00011 Page 18
Women-Owned Small Business Concerns (Mar 2020) (15 U.S.C. 637(m)).
___ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small
Business Concerns Eligible Under the Women-Owned Small Business Program (Mar2020)
(15 U.S.C. 637(m)).
___ (25) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020)(15 U.S.C.
644(r)).
___ (26) 52.219-33, Nonmanufacturer Rule (Mar 2020) (15U.S.C. 637(a)(17)).
__ (27) 52.222-3, Convict Labor (Jun 2003) (£.0.11755).
___ (28) 52.222-19, Child Labor- Cooperation with Authorities and Remedies (Jan2020)
(€.0.13126)
___ (29) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).
__ (30) (i) 52.222-26, Equal Opportunity (Sep 2016) (E.0.11246).
___ (31) (i) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).
___ (ii) Alternate | (Jut 2014) of 52.222-35.
___ (32) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).
__ (ii) Alternate | (JUL 2014) of 52.222-36.
___ (33) 52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).
___ (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec
2010) (E.0. 13496).
___ (35) (i) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.0O.
13627).
__ (ii) Alternate | (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).
__ (36) 52.222-54, Employment Eligibility Verification (Oct 2015). (Executive Order 12989). (Not
applicable to the acquisition of commercially available off-the-shelf items or certain other
types of commercial items as prescribed in 22.1803.)
___ (37) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA—Designated
Items (May 2008) ( 42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of
commercially available off-the-shelf items.)
___ (ii) Alternate | (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the
acquisition of commercially available off-the-shelf items.)
___ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential
Hydrofluorocarbons (Jun 2016) (E.0. 13693).
___ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air
Conditioners (Jun 2016) (E.0. 13693).
___ (40) (i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.0.s
13423 and 13514).
__ (ii) Alternate | (OcT 2015) of 52.223-13.
__ (41) (i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.0.s 13423 and
13514).
___ (ii) Alternate | (Jun2014) of 52.223-14.
___ (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (May
2020) (42 U.S.C. 8259b).
___ (43) (i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OcT
2015) (E.0.s 13423 and 13514).
__ (ii) Alternate | (JUN 2014) of 52.223-16.
___ (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun
2020) (E.0. 13513).
Contract No. 75N92020C00011 Page 19
___ (45) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).
__ (46) 52.223-21, Foams (Jun2016) (E.0. 13693).
__ (47) (i) 52.224-3 Privacy Training (JAN 2017) (5 U.S.C. 552 a).
__ (ii) Alternate | (JAN 2017) of 52.224-3.
___ (48) 52.225-1, Buy American-Supplies (May 2014) (41 U.S.C. chapter 83).
___ (49) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (May
2014) (41 U.S.C.chapter83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19
U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-
283, 110-138, 112-41, 112-42, and 112-43.
__ (ii) Alternate | (May 2014) of 52.225-3.
___ (iii) Alternate Il (May 2014) of 52.225-3.
___ (iv) Alternate Ill (May 2014) of 52.225-3.
___ (50) 52.225-5, Trade Agreements (Oct 2019) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).
___ (51) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.0.’s, proclamations,
and statutes administered by the Office of Foreign Assets Control of the Department of the
Treasury).
___ (52) 52.225-26, Contractors Performing Private Security Functions Outside the United States
(Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal
Year 2008; 10 U.S.C. 2302Note).
___ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov2007) (42 U.S.C. 5150).
___ (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov2007)
(42 U.S.C. 5150).
___ (55) 52.229-12, Tax on Certain Foreign Procurements (JUN 2020).
___ (56) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb
2002) (41 U.S.C. 4505, 10 U.S.C. 2307/(f)).
___ (57) 52.232-30, Installment Payments for Commercial Items (Jan2017)
(41 U.S.C. 4505, 10 U.S.C. 2307(f)).
___ (58) 52.232-33, Payment by Electronic Funds Transfer-System for Award
Management (Oct2018) (31 U.S.C. 3332).
___ (59) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award
Management (Jul 2013) (31 U.S.C. 3332).
___ (60) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).
___ (61) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).
___ (62) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(13)).
___ (63) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (FEB
2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).
___(ii) Alternate | (Apr 2003) of 52.247-64.
__ (iii) Alternate II (Fes 2006) of 52.247-64.
(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial
services, that the Contracting Officer has indicated as being incorporated in this contract by
reference to implement provisions of law or Executive orders applicable to acquisitions of
commercial items:
[Contracting Officer check as appropriate.)
___ (1) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter67).
___(2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May
2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).
___ (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price
Adjustment (Multiple Year and Option Contracts) (Aug
Contract No. 75N92020C00011 Page 20
2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).
___ (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price
Adjustment (May 2014) ( 29U.S.C.206 and 41 U.S.C. chapter 67).
__ (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to
Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May
2014) (41 U.S.C. chapter 67).
__ (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to
Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67).
__ (7) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).
___ (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.O. 13706).
___ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020)
(42.U.S.C. 1792).
(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of
this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the
simplified acquisition threshold, as defined in FAR 2.101, on the date of award of this contract,
and does not contain the clause at 52.215-2, Audit and Records-Negotiation.
(1) The Comptroller General of the United States, or an authorized representative of the
Comptroller General, shall have access to and right to examine any of the Contractor's
directly pertinent records involving transactions related to this contract.
(2) The Contractor shall make available at its offices at all reasonable times the records,
materials, and other evidence for examination, audit, or reproduction, until 3 years after
final payment under this contract or for any shorter period specified in FAR subpart 4.7,
Contractor Records Retention, of the other clauses of this contract. If this contract is
completely or partially terminated, the records relating to the work terminated shall be
made available for 3 years after any resulting final termination settlement. Records relating
to appeals under the disputes clause or to litigation or the settlement of claims arising under
or relating to this contract shall be made available until such appeals, litigation, or claims are
finally resolved.
(3) As used in this clause, records include books, documents, accounting procedures and
practices, and other data, regardless of type and regardless of form. This does not require
the Contractor to create or maintain any record that the Contractor does not maintain in
the ordinary course of business or pursuant to a provision of law.
(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this
clause, the Contractor is not required to flow down any FAR clause, other than those in this
paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the
extent of the flow down shall be as required by the clause-
(i) 52.203-13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509).
(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or
Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further
Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in
subsequent appropriations acts (and as extended in continuing resolutions)).
(iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or
Provided by Kaspersky Lab and Other Covered Entities (JuL 2018) (Section 1634 of Pub. L.
115-91).
Contract No. 75N92020C00011 Page 21
(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video
Surveillance Services or Equipment. (AUG 2019) (Section 889(a)(1)(A) of Pub. L. 115-232).
(v) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)), in
all subcontracts that offer further subcontracting opportunities. If the subcontract (except
subcontracts to small business concerns) exceeds the applicable threshold specified in
FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219-
8 in lower tier subcontracts that offer subcontracting opportunities.
(vi) 52.222-21, Prohibition of Segregated Facilities (APR 2015).
(vii) 52.222-26, Equal Opportunity (Sep 2015) (E.0.11246).
(viii) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).
(ix) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).
(x) 52.222-37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).
(xi) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC
2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR
clause 52.222-40,
(xii) 52.222-41, Service Contract Labor Standards (Aug2018) (41 U.S.C. chapter 67).
(xiii) (A) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.O
13627).
(B) Alternate | (Mar2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).
(xiv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to
Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements
(May2014) (41 U.S.C. chapter 67).
(xv) 52.222-53, Exemption from Application of the Service Contract Labor Standards to
Contracts for Certain Services-Requirements (MAY2014) (41 U.S.C. chapter 67).
(xvi) 52.222-54, Employment Eligibility Verification (Oct 2015) (E.O. 12989).
(xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).
(xviii) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.0. 13706).
(xix) (A) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).
(B) Alternate | (Jan 2017) of 52.224-3.
(xx) 52.225-26, Contractors Performing Private Security Functions Outside the United
States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for
Fiscal Year 2008; 10 U.S.C. 2302 Note).
(xxi) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun
2020) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR
clause 52.226-6.
(xxii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb
2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance
with paragraph (d) of FAR clause 52.247-64.
(2) While not required, the Contractor may include in its subcontracts for commercial items a
minimal number of additional clauses necessary to satisfy its contractual obligations.
(End of clause)
PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS
SECTION J LIST OF ATTACHMENTS
1. Statement of Objectives
2. Mileston payments for letter contract definization
Contract No. 75N92020C00011 Page 22
Attachment 1 — Statement of Objectives
July 27, 2020
Statement of Objectives
Program Title: Rapid Acceleration of Diagnostics (RADx) — Tech
Project Title: Detection of SARS-CoV-2 with the CRISPR-based DETECTR™ platform
Agency: National Institute of Biomedical Imaging and Bioengineering (NIBIB) / National Institutes of Health
(NIH)
1. Background
The National Institute of Biomedical Imaging and Bioengineering (NIBIB) has an open solicitation for
proposals to provide up to $500 million across multiple projects to rapidly produce innovative SARS-CoV-2
diagnostic tests that will assist the public’s safe return to normal activities. Rapid Acceleration of Diagnostics
(RADx), is a fast-track technology development program that leverages the National Institutes of Health
(NIH) Point-of-Care Technology Research Network (POCTRN). RADx will support novel solutions that build
the U.S. capacity for SARS-CoV-2 testing up to 100-fold above what is achievable with standard approaches.
RADx is structured to deliver innovative testing strategies to the public as soon as late summer 2020 and is
an accelerated and comprehensive multi-pronged effort by NIH to make SARS-CoV-2 testing readily available
to every American.
2. Purpose and Objectives
NIBIB is providing substantial support to accelerate the development, validation, and commercialization of
innovative point-of-care and home-based tests, as well as improvements to clinical laboratory tests, that can
directly detect SARS-CoV-2, the virus that causes COVID-19. NIBIB will support the full range of product
development including commercialization and product distribution. The ultimate goal of the RADx program
— across multiple projects/contracts — is to make millions of tests per week available to the American public,
particularly those most vulnerable to and/or disproportionately impacted by COVID-19, in the late summer
of 2020, and having even more tests available in time for the 2020-2021 flu season.
To meet the accelerated timelines, RADx has assembled a national network of expert technical, clinical,
manufacturing, and regulatory advisors who will provide individualized assistance for project development
and commercialization. Funding for projects selected for this program will be dependent on successfully
meeting aggressive project milestones. NIBIB will provide financial and in-kind support to accelerate the
entire product life-cycle, from design to market, for projects that meet milestones successfully. To ensure
that innovations are available to the public as quickly as possible, NIH will leverage established partnerships
with federal agencies, such as FDA, CDC, CMS, ASPR/BARDA, the Department of Defense, as well as
commercial and private entities to propel technologies developed by RADx into widespread use.
The RADx program will consider innovations at all stages of readiness to circumvent current limitations to
SARS-CoV-2 testing capacity, including:
— Early stage: transformative innovations based on novel testing strategies that have potential for
major scale up
— Mid stage: technologies using novel testing strategies that have demonstrated capability but need
further validation, regulatory approval, and scale up
— Advanced stage (RADx ATP): modification and optimization of existing SARS-CoV-2 testing
approaches, including clinical laboratory tests, that can dramatically increase testing capacity. Note:
This arm of the RADx program is addressed under a separate Acquisition Plan.
Page 1 of 4
Attachment 1 — Statement of Objectives
July 27, 2020
Design features might include technical innovations that:
— Improve analytical performance, e.g., sensitivity, specificity, dynamic range, limit of detection,
reliability, accuracy, speed (time to test result) and throughput
— Enhance operational performance through, e.g., development of a patient- and user-friendly design,
use of alternative sampling strategies (e.g., saliva, exhaled breath), integration with mobile-devices,
designs for home-based use or strategies to overcome bottlenecks with current testing approaches
— Improve access and reduce the cost of testing.
3. Scope
RADx-Tech is a two phase program. All applications undergo an intensive week-long risk assessment by a
panel of expert technical, clinical, manufacturing, and regulatory advisors. If the proposed technology meets
viability metrics, projects may be selected to enter phase one.
Phase one, performed under a separate funding mechanism, consists of an accelerated research and
development program in which the awardee receives both financial support and in-kind services through
RADx grant funding. This outcome of this work is a fully instantiated technology ready for clinical validation,
regulatory authorization, production and commercialization.
Phase two, or Work Package 2, of the program, executed under this contract, includes completing the
validation, approval, and production processes in order to deliver a viable product in a scaled up capacity to
the U.S. public.
4. Performance Objectives (Required Results)
A. Contract recipients have completed major research and development efforts and are focused in phase
two on completion of required clinical validation, preparation of regulatory submissions, scale-up of
production capabilities, and preparation for full commercialization of their product — a testing
technology. Every contract will encompass similar expectations and milestones concerned with:
1. meeting regulatory requirements, resulting in regulatory authorization for sale and use of the test;
2. instantiation of agreed-upon production capacity;
3. meeting agreed-upon production goals; and
4. implementation of an agreed-upon commercial strategy to bring the test to market in a timeframe
that will impact the COVID-19 pandemic as soon as possible.
B. Contract funding in phase two is structured in order to reduce risk to the Government, and is dependent
on achievement of specific milestones in the Schedule of Deliverables, according to the Payment
Schedule.
C. The contractor must use a SARS-Cov-2 test with FDA EUA (or will have EUA near the time of award),
indicating a combination of sensitivity, specificity, and usability appropriate to the intended use
according to FDA and/or CDC guidance, as applicable.
D. The contractor must make the product available for independent regulatory/validation assessment. The
independent assessor will be selected by the Government.
Page 2 of 4
Attachment 1 — Statement of Objectives
July 27, 2020
—. In accordance with the goals of the RADx program, the tests/devices produced under this contract are to
be sold within the U.S. and its territories.
F. The contractor must shall provide a risk mitigation plan for each identified stage and update and inform
NIH on any changes/newly identified risks in an ongoing manner
5. Contract Type
The contract type is Firm Fixed Price.
6. Place of Performance
The place of performance will be at the contractor's site.
7. Period of Performance
The period of performance is anticipated to be July 30, 2020 through July 29, 2021.
8. Option for Increased Services
N/A
9. Deliverables/Delivery Schedule
NOTE: Milestones 4-7 will be are not included as part of the Letter Contract and will be included
as part of contract definitization.
Deliverable | Deliverable Due Date
Number
1 Progress Report to NIH documenting supply and vendor agreements and pe
risk mitigation plan — see 4f.
Milestone 1.1f
Oe)
pea
Milestone 1.2:{°
va)
Milestone 137" |
pe I
2 Progress Report to NIH summarizing approved instrument specifications
and risk mitigation plan — see 4f.
Milestone 2.1:[ ]
) I
Milestone 2.2p7 ]
ya) I
Milestone 2.3]
yay
}— i
3 Progress Report to NIH summarizing approved reagent specifications and
risk mitigation plan — see 4f.
Milestone 3.1:
po |
ww
[oxy
Page 3 of 4
Attachment 1 — Statement of Objectives
July 27, 2020
5 Progress Report to NIH with final QC test result for 20 kit or large
(>=10,000 test) lot and risk mitigation plan —see 4f.
Milestone 3. 2p
4 Progress Report to NIH summarizing system verification activities exe
Milestone 4.1}>\*)
Milestone 4. fo
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Milestone 5.1: Pe
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Milestone 5.2:[°
Milestone 5.3:
patients and risk mitigation plan — see 4f.
Milestone 6.2}?
6 Progress Report to NIH documenting EUA submission for symptomatic
Milestone 6.188]
foxy
risk mitigation plan — see 4f.
7 Progress Report to NIH documenting EUA for asymptomatic people and
[ovay
10. Other Requirements
A. The contractor must meet regularly (at least weekly) with NIH officials to update on progress toward
deliverables; anticipated and ongoing issues and problems; and timelines for deliverable completion.
When guided by NIH officials, the contractor must be willing to collaborate and cooperate with external
organizations as needed to meet the contract goals ina manner which will not infringe contractor
commercial or intellectual property rights.
Page 4 of 4
Milestone Payment schedule for contract definitization
Attachment 2
Milestone Payment schedule
Stage Amount
1 Report to NIH documenting supply and vendor agreements
Milestone 11
Day
Milestone 1.2: Pa
Day
Milestone 1.3)
om
Report to NIH summarizing approved instrument specifications.
foway
Report to NIH summarizing approved reagent specifications
pay
yay
Report to NIH summarizing system verification activities
Milestone 4.1:[
Milestone 4.2P9
DKA)
Milestone 4.3: pe
Day
Milestone 4.40
OI)
Report to NIH with final QC test result fof"
Attachment 2
Milestone 5.1}?
DIA)
Milestone 5.2: Pe
pe
Milestone 5.3:
Dy)
Report to NIH documenting EUA submission for symptomatic
Milestone 6.1
Day
Milestone 6.2)
Milestone 6.3.
Milestone 6.4}
Total
Includes Contract Definitization Milestones
poy
SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS
OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30
48N92626c00013 semaTON
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15, DELIVER TO.
National Institutes of Health
National Heart, Lung and Blood
Institute
Bethesda MD 20892-7511
BLDG 1, BETHMC
James A. Shannon Building,
BLDG 1,
1 Center Drive
N/A
Bethesda MD 20892
COE
OFFEROR HLBI INV-BR-A
INHLBI Branch A Invoice
2115 East Jefferson St, MSC 8500
Room 4B-432
Bethesda MD 20892-8500
QUID!
Attn:
9975 Summers Ridge Road
SAN DIEGO CA 92121
ON
(b)(6)
Title: RADx ATP - Accelerated Manufacturing
IScale-Up of Rapid Point-of-Care Antigen Tests for
[COVID-19 Diagnosis
[This Letter Contract forms a preliminary
jlunderstanding between Quidel Corporation and the
National Institutes of Health (NIH) and is issued
jas a result of the Rapid Acceleration of
Diagnostics Advanced Technology Platforms
(RADx-ATP) to increase the Scale-Up for the
manufacturing capacity of Sofia SARS Antigen and
(Use Reverse and/or Attach Additional Sheets as Necessary)
25, ACCOUNTING AND APPROPRIATION DATA
See schedule $3,000,000.00
278. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 62.212-4. FAR §2.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA CARE 1] ARE NOT ATTACHED.
O27. CONTRACTIPURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5ISATTACHED. ADDENDA Clare CJARE NOT ATTACHED.
[CD 29. AWARD OF CONTRACT: OFFER
DATED ___. YOUR OFFER ON SOLICITATION (BLOCK 5),
INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH
HEREIN. IS ACCEPTED AS TO ITEMS:
jubigitaliysigned bycomelius
. O. Moore -S
Date: 2020.07.30 11:43:17
‘or pring
‘TOTAL AWARD AMOUNT (For Govt. Use Only)
28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN =
COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER
ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL
SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.
brrorexco once SOOSTTS ‘STANDARD FORM 1449 (REV. 2/2012)
PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212
20.
‘SCHEDULE OF SUPPLIESISERVICES.
Sofia Influenza A+B/SARS FIAs testing platforms
for detecting SARS-CoV-2, the virus that causes
COVID-19. This Letter Contract is an
Undefinitized Contract Action that will be
definitized in accordance with the schedule
contained herein.
Delivery: 07/29/2021
Period of Performance: 07/30/2020 to 07/29/2021
1 RADx- ATPadditional headcount
Project Data:
151796-2020.100-HNA1 OD IOD IMMEDIATE OFFICE OF
THE DIRECTOR-25235 ALL OTHER SERVICES
{NON-FEDERAL SOURCES) -07/29/2020
Accounting Info:
2 RADx project - Modification of Manufacturing
Project Data:
151796-2020.100-HNAl OD IOD IMMEDIATE OFFICE OF
THE DIRECTOR-25235 ALL OTHER SERVICES
(NON-FEDERAL SOURCES) -07/29/2020
Continued ...
32a, QUANTITY IN COLUMN 21 HAS BEEN
[(D) RECEIVED (INSPECTED (C] ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:
‘3b, SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE or | ‘32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE
32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 321. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE
/329. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE
33. SHIP NUMBER. . VOUCHER NUMBER [35. AMOUNT VERIFIED ‘37. CHECK NUMBER,
CORRECT FOR
(PARTIAL
38, SIR ACCOUNT NUMBER oon |40. PAID BY
eee 42a. RECEIVED BY (Print)
41b, SIGNATURE AND TITLE OF CERTIFYING OFFICER
42b. RECEIVED AT (Location)
DATE RECD (YYMMDD) 424, TOTAL CONTAINERS
STANDARD FORM 1449 (REV, 2/2012) BACK
;RENCE NO, OF DOCUMENT BEING CONTINUED
CONTINUATION SHEET
oF
175N92020C00013 5 3
NAME OF OFFEROR OR CONTRACTOR
QUIDEL CORPORATION
ITEM NO. SUPPUESISERVICES ‘QUANTITY | UNIT UNIT PRICE ‘AMOUNT
(A) (B) (c) (D} (E) (F)
Accounting Info:
(08034620200DAD-2020-81-A100-EMHNA10000C-E-C4490~-40
|6-COVD-25235-9999-9999-9999-151796-2020.100-HNAL
}OD IOD IMMEDIATE OFFICE OF THE
DIRECTOR-07/29/2020-25235 ALL OTHER SERVICES
(NON-FE)
DERAL SOURCES) -8046555
NSN 7540-01-152-0067
‘OPTIONAL FORM 336 (4-86)
‘Sponsored by GSA
FAR (48 CFR) 53,110
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
ARTICLE B.1. BRIEF DESCRIPTION OF SERVICES
This Letter Contract forms a preliminary understanding between Quidel Corporation and the National Institutes
of Health (NIH) and is issued as a result of the Rapid Acceleration of Diagnostics Advanced Technology Platforms
(RADx-ATP) to increase the testing capacity of high throughput labs by scaling up late stage testing platforms for
detecting SARS-CoV-2, the virus that causes COVID-19. Issuance of this Letter Contract authorizes the
Contractor to immediately begin the activities necessary to perform the requirements as identified in the
Statement of Objectives covering the full range of activities needed to increase capacity and optimize
throughput necessary to distribute a viable product to the public.
The scope of work executed under this contract, includes completing the validation, approval, and production
processes in order to deliver a viable product in a scaled up capacity to the U.S. public.
This Letter Contract has been issued based on the the submission by the contractor under the RADx-ATP
program, which includes the application and preliminary work file and subsequent documentation submitted
during the review process. The Contractor’s inability to meet the requirements as defined within this Letter
Contract and proposed within the application process may result in the termination of the Letter Contract in
accordance with the termination clauses contained herein.
ARTICLE B.2. PRICES
a. The total Firm Fixed Price (FFP) amount for this contract is $3,000,000.
Pricing Schedule
Milestone Date Test/Da Description Price
1 8/3/2020 |” a
2 9/14/2020
ARTICLE B.3. ADVANCE UNDERSTANDINGS
a. The parties acknowledge and agree that the situation around COVID-19 is highly dynamic, evolving
rapidly, and subject to significant uncertainty. The Letter Contract is being executed on an expedited
timeline to meet an urgent and compelling government need without the benefit of prior negotiation.
Thus, the parties will negotiate in good faith to ensure that the definitized contract reflects an
appropriate allocation of risk and responsibility and that it is consistent with the application and
preliminary work file submitted by the contractor and subsequent documentation submitted during the
application review process and the discussions between the parties that have taken place between date
of application submission through Letter Contract issuance. Until the Performance Work Statement
(PWS) is finalized the Statement of Objective (SOO) will govern.
b. The parties anticipate that the definitive contract resulting from this Letter Contract will include a
negotiated firm fixed price not to exceed $71,000,000. The amount of funding provided for this Letter
Contract is stated in Article B.2 above, the contractor shall not invoice in excess of this amount.
Contract No. 75N92020C00013 Page 1
c. Commercial Item Status: The services provided by the Contractor under the Letter contract and any
definitized contract constitute commercial item services, and the terms of any definitized contract will
reflect that understanding.
d. Performance Work Statement: The parties will continue to negotiate the Performance Work Statement
in the process of contract definitization to fairly reflect the application and preliminary work file
submitted by the contractor and subsequent documentation submitted during the application review
process and the discussions between the parties that have taken place between application submission
through letter contract issuance.
e. HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to
include rating this order in accordance with 45 CFR Part 101, Subpart A—Health Resources Priorities and
Allocations System.
f. The parties agree prior to negotiate further the terms of milestone payments to include in the
definitized contract. In the negotiation, the parties will consider terms addressing liquidation of
milestone payments.
g. Successful performance under this contract requires the Contractor obtain and maintain an Emergency
Use Authorization (EUA) from the Food and Drug Administration (FDA); the Contractor shall copy us on
all FDA correspondence related to the project, including email communications to and from the FDA.
The FDA EUA services provided under this Letter Contract constitute a commercial service to detect
SARS-CoV-2.
h. Fair Pricing: The Rapid Acceleration of Diagnostics (RADx) application review process determined the
cost per test is competitive with the current market price. The Contractor must comply with applicable
federal law to ensure that prices to consumers are offered at fair market rate and at a rate consistent
with the objective to increase and improve testing in the United States.
i. In accordance with the goals of the RADx program, the testing capabilities produced under this contract
are to be for utilization within the U.S. and its territories.
j. Sharing Data and Reports: The Contractor will be required to provide data and reports (e.g.,
manufacturing, supply chain, production rates), which NIH will use to evaluate completion or
achievement of milestones, progress toward deliverables, and compliance with the requirements of the
contract. NIH may use the data to coordinate with other U.S. Government Agencies to accelerate
development and deployment of innovative COVID-19 diagnostic tests, and ensure effective stewardship
of federal funds. Sharing data within the federal government enables NIH to discuss the project’s
challenges and progress with federal agencies offering scientific, manufacturing, and logistics expertise.
To ensure that innovations are available to the public as quickly as possible, NIH will leverage
established partnerships with federal agencies, such as FDA, CDC, CMS, ASPR/BARDA, and the
Department of Defense, and partnerships with State agencies to propel technologies developed by RADx
into widespread use.
k. Security and Privacy of Protected Health Information (PHI) processed under this contract: The
Contractor shall meet the definition of either a Covered Entity or Business Associate under the Health
Insurance Portability and Accountability Act of 1996 (HIPAA). The contractor shall therefore comply
with the HIPAA regulatory standards set forth in the Code of Federal Regulations (CFR) 45 C.F.R. Part
Contract No. 75N92020C00013 Page 2
160, Part 162, and Part 164. To the extent that the Contractor engages subcontractors or other Business
Associates to provide services under this Contract, and such Subcontractors or Business Associates will
receive or create protected health information (PHI) on behalf of the contractor, the contractor shall
obtain satisfactory assurances from its business associate that the business associate will appropriately
safeguard the protected health information. The satisfactory assurances must be in writing, whether in
the form of a contract or other agreement between the Contractor and the business associate. In the
event of a suspected or known security or privacy breach, in addition to following the procedures set
forth in 45 C.F.R. Part 164, the contractor shall also immediately notify the NIH via the Contracting
Officer (CO) and the Contracting Officer's Representative (COR).
|. Contractor Facilities: The contractor shall certify that they will maintain their Facility and Equipment in
satisfactory operating condition, as required to enable the contractor to manufacture the Final Product
to Specification in accordance with the Scaled up Process and all other applicable laws, regulations, rules
or orders. Routine repairs, preventive maintenance, and service contracts for the Facility and Equipment
shall be arranged by contractor at no additional cost to the Government.
m. Letter Contract Termination: FAR 52.212-4 (I) Termination for the Government's convenience. The
Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In
the event of such termination, the Contractor shall immediately stop all work hereunder and shall
immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of
this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of
the work performed prior to the notice of termination, plus reasonable charges the Contractor can
demonstrate to the satisfaction of the Government using its standard record keeping system, have
resulted from the termination. The Contractor shall not be required to comply with the cost accounting
standards or contract cost principles for this purpose. This paragraph does not give the Government any
right to audit the Contractor’s records. The Contractor shall not be paid for any work performed or costs
incurred which reasonably could have been avoided.
In accordance with FAR 52.212-4(m), the Government may terminate this contract, or any part hereof,
for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any
contract terms and conditions, or fails to provide the Government, upon request, with adequate
assurances of future performance. In the event of termination for cause, the Government shall not be
liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall
be liable to the Government for any and all rights and remedies provided by law. If it is determined that
the Government improperly terminated this contract for default, such termination shall be deemed a
termination for convenience.
n. The Contractor shall meet the definition of either a Covered Entity or Business Associate under the
Health Insurance Portability and Accountability Act of 1996 (HIPAA). The contractor shall therefore
comply with the HIPAA regulatory standards set forth in the Code of Federal Regulations (CFR) 45 C.F.R.
Part 160, Part 162, and Part 164. To the extent that the Contractor engages subcontractors or other
Business Associates to provide services under this Contract, and such Subcontractors or Business
Associates will receive or create protected health information (PHI) on behalf of the contractor, the
contractor shall obtain satisfactory assurances from its business associate that the business associate
will appropriately safeguard the protected health information. The satisfactory assurances must be in
writing, whether in the form of a contract or other agreement between the Contractor and the business
associate. In the event of a suspected or known security or privacy breach, in addition to following the
procedures set forth in 45 C.F.R. Part 164, the contractor shall also immediately notify the NIH via the
Contract No. 75N92020C00013 Page 3
Contracting Officer (CO) and the Contracting Officer’s Representative (COR).
o. The parties agree to address HHS Information Security and Privacy Requirements, as applicable, during
definitization of the contract.
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
ARTICLE C.1, STATEMENT OF OBJECTIVES
Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services,
qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed
to perform the Statement of Objectives, dated July 25, 2020, set forth in SECTION J — List of Attachments,
attached hereto and made a part of this Leter Contract. Work to be performed shall be consistent with the
application and preliminary work file submitted by the Contractor and subsequent documentation submitted
during the application review process and the discussions between the parties that have taken place between
date of application submission through Letter Contract award.
ARTICLE C.2. REPORTING REQUIREMENTS
All reports required herein shall be submitted in electronic format only. All electronic reports submitted shall be
compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents
for Section 508 compliance, including guidance and specific checklists, by application, can be found at:
http://www.hhs.gov/web/508/index.htm! under "Making Files Accessible." Additional reporting will be
negotiated and included upon contract definitization.
Item number Deliverable Title Due Date
1 Risk Management Plan 8/21/2020
2 Recurring reports (inclusive of scale up progress, challenges, Weekly
status of management of adequate supply chain, current
production capacity)
3 Detailed plan to address supply chain shortages and related 08/07/2020
delays, followed by updates to this plan, as appropriate
4 Final plan/approach and timeline for manufacturing line 08/10/2020
modifications to meet scale-up requirements of? fofia
SARS Antigen FIA tests per day by June 30, 2021
5 Final plan/approach for rapidly deploying the product to Point- 08/14/2020
of-Care settings
6 Plan to collect post-market data to support a PMA/510(k) 08/14/2020
submission; share data with NIH; update clinical validity
measures; and monitor differences in test results by type of
specimen, collection device, user setting, and other variables
that may impact test performance/results
7 Report on the plan to collect post-market data as described in Monthly
3.e
8 Report on the submission of permits for space 08/10/2020
renovation/construction, as appropriate
9 Report on the demonstration of increased capacity to pe | 08/31/2020
Contract No. 75N92020C00013 Page 4
Sofia SARS Antigen FIA tests/day
10 Report on the demonstrated capability for using FHIR- 08/31/2020
based APIs for standardized electronic data transmission,
or a plan for implementing such a capability within two
months of letter contract ratification.
SECTION D — PACKAGING, MARKING, AND SHIPPING
There are no additional instructions or specifications applicable to this contract other than the delivery
instructions contained herein.
SECTION E - INSPECTION AND ACCEPTANCE
a. The Contracting Officer or the duly authorized Contracting Officer’s Representative (COR) will perform
inspection and acceptance of deliverables to be performed and the milestones to be achieved.
b. Inspection and acceptance will be performed as identified in the contract requirements.
SECTION F - DELIVERIES OR PERFORMANCE ARTICLE F.1. PERIOD OF PERFORMANCE
The period of performance of this letter contract is anticipated to be July 30, 2020 through September 16, 2020.
The period of performance upon contract definitizatin will be July 30, 2020 through July 29, 2021.
ARTICLE F.2. DELIVERIES
Satisfactory performance shall be deemed to occur upon performance of the work described in the Statement of
Work Article in SECTION C of this contract and upon notice and acceptance by the Contracting Officer, or the
duly authorized representative, in accordance with the stated delivery schedule.
The deliverables or documentation shall be submitted to the Contracting Officer or designated Contracting
Officer Representative (COR).
SECTION G - CONTRACT ADMINISTRATION DATA
ARTICLE G.1. CONTRACTING OFFICER (CO)
The following Contracting Officer (CO) will represent the Government for the purpose of
this contract:
Name: Cornelius Moore
Telephone: 301-827-7730
Email: mooreco@mail.nih.gov
The Contracting Officer is the only person with authority to act as agent of the Government
under this contract. Only the Contracting Officer has authority to:
1) direct or negotiate any changes in the statement of work;
2) modify or extend the period of performance;
3) change the delivery schedule;
4) authorize reimbursement to the Contractor for any costs incurred during the performance of this
contract;
Contract No. 75N92020C00013 Page 5
5) otherwise change any terms and conditions of this contract; or
6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in
Section K of the contract.
All correspondence (including invoices) that proposes or otherwise involves waivers,
deviations, or modifications to requirement shall be provided to the CO issuing the contract and the COR
supporting the CO.
ARTICLE G.2. CONTRACTING OFFICER'S REPRESENTATIVE (COR)
The following Contracting Officer's Representative (COR) is anticipated to represent the Government for
the purpose of this contract:
Dr. Olga Hartman
Telephone: 301-496-3500
Email: olga.hartman@nih.gov
The COR is responsible for:
(1) monitoring the Contractor's technical progress, including the surveillance and assessment of
performance and recommending to the Contracting Officer changes in requirements;
(2) interpreting the statement of work and any other technical performance requirements;
(3) performing technical evaluation as required;
(4) performing technical inspections and acceptances required by this contract; and
(5) assisting in the resolution of technical problems encountered during performance.
The Government may unilaterally change the COR designation.
ARTICLE G.3. PRIMARY PROGRAM MANAGER
The Primary Program Manager specified in this contract is considered essential to work performance. At
least 30 calendar days prior to any changes to the individual listed below to other programs or contract (or
as soon as reasonably possible, if an individual must be replaced, for example, as a result of leaving the
employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit
comprehensive justification for the change request (including proposed substitutions for primary program
manager) to permit evaluation by the Government of the impact on performance under this contract. The
Contractor shall not replace any primary program manager without the written consent of the Contracting
Officer. The Government may modify the contract to add or delete primary program manager at the
request of the contractor or Government. In no case shall the individual’s effort exceed 100% across all
contract.
ye)
ARTICLE G.4. INVOICE SUBMISSION
In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include
the following information on the face page of all contract payment requests:
Contract No. 75N92020C00013 Page 6
a. The Contract Title is: RADx ATP 6313 Quidel - Manufacturing Capacity Scale-Up for Sofia SARS Antigen
and Sofia Influenza A+B/SARS FIAs
b. The Contract Line Items are defined within the Section 20. Schedule of Supplies/Services of the Standard
Form 1449.
c. Invoice Instructions are attached and made part of this contract. The Contractor shall follow the
attached instructions and submission procedures specified below to meet the requirements of a "proper
invoice" pursuant to FAR Subpart 32.9, Prompt Payment.
1. Payment requests shall be submitted to the offices identified below. Do not submit supporting
documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your payment request unless
specified elsewhere in the contract or requested by the Contracting Officer.
a. One copy of the invoice shall be submitted to the approving official at the following email
addresses:
NHLBI Branch A Central Mailbox (NHLBIContractsBranchA@mail.nih.gov)
NIH centralized invoice email box: invoicing@nih.gov
2. E-Mail: The Contractor shall submit an electronic copy of the payment request to the approving
official. The payment request shall be transmitted as an attachment via e-mail to the address listed
above in one of the following formats: MSWord, MS Excel, or Adobe Portable Document Format
(PDF). Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall
include the Contractor's name, contract number, and unique invoice number.
3. In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall
include the following information on the face page of all payment requests (invoices):
a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is NHLBI.
b. Central Point of Distribution. For the purpose of this contract, the Central Point of Distribution is
NHLBI Branch A Invoices.
c. Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall
identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number
that appears after the Contractor's name on the face page of the contract. [Note: A VIN is
assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to
include the VIN number.] \f the Contractor has neither a TIN, DUNS, or VIN, contact the
Contracting Officer.
d. DUNS or DUNS+4 Number. The DUNS number must identify the Contractor's name and address
exactly as stated in the contract and as registered in the Central Contractor Registration (CCR)
database. If the Contractor does not have a valid DUNS number, it shall identify the Vendor
Identification Number (VIN) on the payment request. The VIN is the number that appears after
the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts
awarded on or after June 4, 2007, and any existing contract modified to include the VIN
number.] \f the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.
e. Invoice Matching Option. This contract requires a two-way match.
f. Unique Invoice Number. Each payment request must be identified by a unique invoice number,
which can only be used one time regardless of the number of contracts or orders held by an
organization.
Contract No. 75N92020C00013 Page 7
g. PRISM/NBS Line Item Number and associated PRISM/NBS Line Item Period of Performance (see
Section B — PRICES).
d. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-6088.
SECTION H - ADDITONAL CONTRACT CLAUSES
ARTICLE H.1. SUBCONTRACTING PROVISIONS
a. Small Business Subcontracting Plan
The parties agree to address the requirements of this Article during definitization of the contract.
1. The Small Business Subcontracting Plan, dated, is attached hereto and made a
part of this contract.
2. The failure of any Contractor or subcontractor to comply in good faith with FAR Clause 52.219-8,
entitled "Utilization of Small Business Concerns" incorporated in this contract and the attached
Subcontracting Plan, will be a material breach of such contract or subcontract and subject to the
remedies reserved to the Government under FAR Clause 52.219-16 entitled, "Liquidated
Damages-Subcontracting Plan."
b. Subcontracting Reports
The Contractor shall submit the following Subcontracting reports electronically via the "electronic
Subcontracting Reporting System (eSRS) at http://www.esrs.gov.
1. Individual Subcontract Reports (ISR)
Regardless of the effective date of this contract, the Report shall be due on the following
dates for the entire life of this contract:
April 30th October 30th
Expiration Date of Contract
Summary Subcontract Report (SSR)
2. Regardless of the effective date of this contract, the Summary Subcontract Report shall be
submitted annually on the following date for the entire life of this contract:
October 30th
For both the Individual and Summary Subcontract Reports, the Contracting Officer shall be included
as a contact for notification purposes at the following e-mail address:
Cornelius Moore mooreco@mail.nih.gov
Contracting Officer
ARTICLE H.2. CONFIDENTIALITY OF INFORMATION
a. Confidential information, as used in this article, means information or data of a personal
nature about an individual, or proprietary information or data submitted by or pertaining
to an institution or organization.
Contract No. 75N92020C00013 Page 8
b. The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this
contract specific information and/or categories of information which the Government will
furnish to the Contractor or that the Contractor is expected to generate which is confidential.
Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such
confidential information from time to time during the performance of the contract. Failure to
agree will be settled pursuant to the "Disputes" clause.
c. Ifit is established elsewhere in this contract that information to be utilized under this contract, or
a portion thereof, is subject to the Privacy Act, the Contractor will follow the rules and procedures
of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and
policies, with respect to systems of records determined to be subject to the Privacy Act.
d. Confidential information, as defined in paragraph (a) of this article, shall not be disclosed without
the prior written consent of the individual, institution, or organization.
e. Whenever the Contractor is uncertain with regard to the proper handling of material under the
contract, or if the material in question is subject to the Privacy Act or is confidential information
subject to the provisions of this article, the Contractor should obtain a written determination
from the Contracting Officer prior to any release, disclosure, dissemination, or publication.
f. Contracting Officer determinations will reflect the result of internal coordination with
appropriate program and legal officials.
g. The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping
provisions in other Federal, State or local laws.
ARTICLE H.3. PUBLICATION AND PUBLICITY
In addition to the requirements set forth in HHSAR Clause 352.227-70, Publications and Publicity
incorporated by reference in SECTION | of this contract, the Contractor shall acknowledge the
support of the National Institutes of Health whenever publicizing the work under this contract in any
media by including an acknowledgment substantially as follows:
"This project has been funded in whole or in part with Federal funds from the Office of the
Director, National Institutes of Health, Department of Health and Human Services, under
Contract No. 75N92020C00013”
ARTICLE H.4. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE
Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in
NIH funded programs is encouraged to report such matters to the HHS Inspector General's Office
in writing or on the Inspector General's Hotline. The toll free number is 1-800-HHS-TIPS (1-800-
447-8477). All telephone calls will be handled confidentially. The website to file a complaint on-
line is: http://oig.hhs.gov/fraud/hotline/ and the mailing address is:
Contract No. 75N92020C00013 Page 9
US Department of Health and Human Services Office of Inspector
General
ATTN: OIG HOTLINE OPERATIONS
P.O. Box 23489 Washington, D.C. 20026
PART II - CONTRACT CLAUSES SECTION | - CONTRACT CLAUSES
ARTICLE I.1. ADDITIONAL CONTRACT CLAUSES
This contract incorporates the following clauses by reference, (unless otherwise noted), with the same force and
effect as if they were given in full text. The parties agree to address the requirement of this Article during
definitization of the letter contract
HHSAR Clause 352.227-70, Publication and Publicity
FAR Clause 25.212-3, Offeror Representation and Certification — Commercial Items (Jun 2020)
FAR Clause 52.212-3, Offeror Representations and Certifications - Commercial Items (Jun 2020)
FAR Clause 52.212-4 Contract Terms and Conditions - Commercial Items (Oct 2018)
FAR Clause 52.203-13, Contractor Code of Business Ethics and Conduct (October 2015)
FAR Clause 52.204-2, Security Requirements (August 1996).
1. Alternate | (April 1984) is not applicable to this contract.
2. Alternate II (April 1984) is not applicable to this contract.
g. FAR Clause 52.204-9, Personal Identity Verification of Contractor Personnel (January 2011).
h. FAR Clause 52.204-13, System for Award Management Maintenance
i
J
>paooe
FAR Clause 52.204-18 Commercial and Government Entity Code Maintenance (July 2016)
FAR Clause 52.204-23 Prohibition on Contracting for Hardware, Software, and Services Developed or
Provided by Kaspersky Lab and Other Covered Entities
k. FAR Clause 52.209-10, Prohibition on Contracting With Inverted Domestic Corporations(November
2015).
|. FAR Clause 52.222-4, Contract Work Hours and Safety Standards - Overtime Compensation -General
(May 2014).
. FAR Clause 52.222-29, Notification of Visa Denial (April 2015).
FAR Clause 52.223-15, Energy Efficiency in Energy-Consuming Products (December 2007).
FAR Clause 52.224-1, Privacy Act Notification (April 1984).
FAR Clause 52.224-2, Privacy Act (April 1984).
FAR Clause 52.227-14, Rights in Data - General (May 2014).
FAR Clause 52.227-14, Rights in Data - General (May 2014) Alternate II (Dec 2007).
FAR Clause 52.232-40, Providing Accelerated Payments to Small Business Subcontractors
yrapes3
ARTICLE 1.2. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT
1. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES
Additional clauses other than those listed below which are based on the type of contract/Contractor
shall be determined during negotiations. This contract incorporates the following clauses in full text.
1. FAR 52.216-23 - EXECUTION AND COMMENCMENT OF WORK (APR 1984)
Contract No. 75N92020C00013 Page 10
The Contractor shall indicate acceptance of this letter contract by signing One Copy of the contract
and returning it to the Contracting Officer not later than July 30, 2020 12:00PM Eastern. Upon
acceptance by both parties, the Contractor shall proceed with performance of the work, including
purchase of necessary materials.
2. FAR 52.216-24 - LIMITATION OF GOVERNMENT LIABILITY (APR 1984)
(a) In performing this contract, the Contractor is not authorized to make expenditures orincur
obligations exceeding $3,000,000.
(b) The maximum amount for which the Government shall be liable if this contract is terminated is
$3,000,000.
3. FAR 52.216-25 - CONTRACT DEFINITIZATION (OCT 2010)
(a) A Firm Fixed Price (FFP) definitive contract is contemplated. The Contractor agrees to begin promptly
negotiating with the Contracting Officer the terms of a definitive contract that will include (1) all clauses
required by the Federal Acquisition Regulation (FAR) on the date of execution of the letter contract, (2) all
clauses required by law on the date of execution of the definitive contract, and (3) any other mutually
agreeable clauses, terms, and conditions. The Contractor agrees to submit a Firm Fixed Price proposal,
including data other than certified cost or pricing data, , in accordance with FAR 15.408, Table 15-2,
supporting its proposal.
The Schedule for definitizing this contract is as follows:
Definitization Schedule Date
Statement of Objectives Review 07/25/2020
Issuance of Letter Contract 07/30/2020
Letter Contract Post Award Kick Off meeting 07/31/2020
Contractor Technical and Revised Price 08/14/2020
Proposal Submittal, to include subcontracting
plan if applicable
Request Other than certified cost or pricing 08/21/2020
data
Project Officer’s Technical 08/25/2020
Questionnaire/Technical Evaluation & Review
Negotiations Start 08/27/2020
Definitization of Letter Contract (Target Date) 09/16/2020
(b) If agreement on a definitive contract to supersede this letter contract is not reached by the target
date in paragraph (b) of this section, or within any extension of it granted by the Contracting
Officer, the Contracting Officer may, with the approval of the head of the contracting activity,
determine a reasonable price or fee in accordance with subpart 15.4 and part 31 of the FAR,
subject to Contractor appeal as provided in the Disputes clause. In any event, the Contractor shall
proceed with completion of the contract, subject only to the Limitation of Government Liability
clause.
(1) After the Contracting Officer’s determination of price or fee, the contract shallbe governed
by-
Contract No. 75N92020C00013 Page 11
(i) All clauses required by the FAR on the date of execution of this letter contract for
either fixed-price or cost-reimbursement contracts, as determined by the Contracting
Officer under this paragraph (c);
(ii) All clauses required by law as of the date of the Contracting Officer’s determination;
and
(iii) Any other clauses, terms, and conditions mutually agreed upon.
(2) To the extent consistent with paragraph (c)(1) of this section, all clauses, terms, and
conditions included in this letter contract shall continue in effect, except those that by their
nature apply only to a letter contract.
(c) FAR Clause 52.204-21, Basic Safeguarding of Covered Contractor Information Systems (Jun
2016)
(a) Definitions. As used in this clause—
Covered contractor information system means an information system that is owned or
operated by a contractor that processes, stores, or transmits Federal contract
information.
Federal contract information means information, not intended for public release, that is
provided by or generated for the Government under a contract to develop or deliver a
product or service to the Government, but not including information provided by the
Government to the public (such as on public websites) or simple transactional
information, such as necessary to process payments.
Information means any communication or representation of knowledge such as facts,
data, or opinions, in any medium or form, including textual, numerical, graphic,
cartographic, narrative, or audiovisual (Committee on National Security Systems
Instruction (CNSSI) 4009).
Information system means a discrete set of information resources organized for the
collection, processing, maintenance, use, sharing, dissemination, or disposition of
information (44 U.S.C. 3502).
Safeguarding means measures or controls that are prescribed to protect information
systems.
(b) Safeguarding requirements and procedures.
(1) The Contractor shall apply the following basic safeguarding requirements and
procedures to protect covered contractor information systems. Requirements and
procedures for basic safeguarding of covered contractor information systems shall
include, at a minimum, the following security controls:
(i) Limit information system access to authorized users, processes acting on behalf of
authorized users, or devices (including other information systems).
Contract No. 75N92020C00013 Page 12
ii) Limit information system access to the types of transactions and functions that
authorized users are permitted to execute.
iii) Verify and control/limit connections to and use of external information systems.
iv) Control information posted or processed on publicly accessible information
systems.
v) Identify information system users, processes acting on behalf of users, or devices.
vi) Authenticate (or verify) the identities of those users, processes, or devices, as a
prerequisite to allowing access to organizational information systems.
vii) Sanitize or destroy information system media containing Federal Contract
Information before disposal or release for reuse.
viii) Limit physical access to organizational information systems, equipment, and the
respective operating environments to authorized individuals.
ix) Escort visitors and monitor visitor activity; maintain audit logs of physical access;
and control and manage physical access devices.
x) Monitor, control, and protect organizational communications (i.e., information
transmitted or received by organizational information systems) at the external
boundaries and key internal boundaries of the information systems.
xi) Implement subnetworks for publicly accessible system components that are
physically or logically separated from internal networks.
xii) Identify, report, and correct information and information system flaws in a timely
manner.
xiii) Provide protection from malicious code at appropriate locations within
organizational information systems.
xiv) Update malicious code protection mechanisms when new releases are available.
xv) Perform periodic scans of the information system and real-time scans of files from
external sources as files are downloaded, opened, or executed.
(2) Other requirements. This clause does not relieve the Contractor of any other specific
safeguarding requirements specified by Federal agencies and departments relating to
covered contractor information systems generally or other Federal safeguarding
requirements for controlled unclassified information (CUI) as established by Executive
Order 13556.
(c) Subcontracts. The Contractor shall include the substance of this clause, including this
paragraph (c), in subcontracts under this contract (including subcontracts for the
Contract No. 75N92020C00013 Page 13
acquisition of commercial items, other than commercially available off-the-shelf items), in
which the subcontractor may have Federal contract information residing in or transiting
through its information system.
(End of clause)
4, FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-
Commercial Items (Jul 2020)
(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses,
which are incorporated in this contract by reference, to implement provisions of law or
Executive orders applicable to acquisitions of commercial items:
(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or
Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further
Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in
subsequent appropriations acts (and as extended in continuing resolutions)).
(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or
Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L.
115-91).
(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video
Surveillance Services or Equipment. (Aug 2019) (Section 889(a)(1)(A) of Pub. L. 115-
232).
(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov
2015).
(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).
(6) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and
108-78 ( 19 U.S.C. 3805 note)).
(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting
Officer has indicated as being incorporated in this contract by reference to implement
provisions of law or Executive orders applicable to acquisitions of commercial items: The parties
agree to address the requirements of this Article during definization of the contract.
[Contracting Officer check as appropriate]
Selections will be made by the Contracting Officer during definitization.
___ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (JUNE 2020),
with Alternate | (Oct 1995) ( 41U.S.C.4704 and 10 U.S.C. 2402).
___ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509)).
___ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment
Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the
American Recovery and Reinvestment Act of 2009.)
___ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN
Contract No. 75N92020C00013 Page 14
2020) (Pub. L. 109-282) ( 31.U.S.C. 6101 note).
___(5) [Reserved].
___ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section
743 of Div. C).
___(7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery
Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).
___ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors
Debarred, Suspended, or Proposed for Debarment. (JUN 2020) (31 U.S.C. 6101 note).
___ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (OcT
2018) (41 U.S.C. 2313).
___ (10) [Reserved].
___ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (MAR
2020) (15 657a).
___ (ii) Alternate | (Mar 2020) of 52.219-3.
___ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business
Concerns (Mar 2020) (if the offeror elects to waive the preference, it shall so indicate in its
offer) (15 U.S.C. 657a).
__ (ii) Alternate | (Mar 2020) of 52.219-4.
___ (13) [Reserved]
___ (14) (i) 52.219-6, Notice of Total Small Business Set-Aside (Mar 2020) of 52.219-
6 (15 U.S.C. 644).
__ (ii) Alternate | (Mar 2020) of 52.219-6 .
___ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (Mar 2020) (15 U.S.C. 644).
___ (ii) Alternate | (Mar 2020) of 52.219-7.
___ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).
___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Jun 2020) (15 U.S.C. 637(d)(4)).
ii) Alternate | (Nov 2016) of 52.219-9.
__ (iii) Alternate II (Nov 2016) of 52.219-9.
___(iv)Alternate III (Jun 2020) of 52.219-9.
__ (v)Alternate IV (JUN 2020) oF 52.219-9
___ (18) (i) 52.219-13, Notice of Set-Aside of Orders (Mar 2020) (15 U.S.C. 644(r)).
___ (ii) Alternate | (Mar 2020) of 52.219-13.
___ (19) 52.219-14, Limitations on Subcontracting (Mar 2020) (15 U.S.C. 637(a)(14)).
___ (20) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan
1999) (15 U.S.C, 637(d)(4)(F)(i)).
___ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Mar
2020) (15 U.S.C. 657f).
___ (22) (i) 52.219-28, Post Award Small Business Program Rerepresentation (May
2020) (15 U.S.C. 632(a)(2)).
___ (ii) Alternate | (MAR 2020) of 52.219-28.
___ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged
Women-Owned Small Business Concerns (Mar 2020) (15 U.S.C. 637(m)).
___ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small
Business Concerns Eligible Under the Women-Owned Small Business Program (Mar2020)
(15 U.S.C. 637(m)).
___ (25) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020)(15 U.S.C.
644(r)).
___ (26) 52.219-33, Nonmanufacturer Rule (Mar 2020) (15U.S.C. 637(a)(17)).
Contract No. 75N92020C00013 Page 15
___ (27) 52.222-3, Convict Labor (Jun 2003) (E.0.11755).
___ (28) 52.222-19, Child Labor- Cooperation with Authorities and Remedies (Jan2020)
(E.0.13126)
___ (29) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).
__ (30) (i) 52.222-26, Equal Opportunity (Sep 2016) (E.0.11246).
___ (ii) Alternate | (Fes 1999) of 52.222-26.
___ (31) (i) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).
__ (ii) Alternate | (JuL 2014) of 52.222-35.
___ (32) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).
__ (ii) Alternate | (JUL 2014) of 52.222-36.
___ (33) 52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).
___ (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec
2010) (E.0. 13496).
___ (35) (i) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.O.
13627).
__ (ii) Alternate | (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).
___ (36) 52.222-54, Employment Eligibility Verification (Oct 2015). (Executive Order 12989). (Not
applicable to the acquisition of commercially available off-the-shelf items or certain other
types of commercial items as prescribed in 22.1803.)
___ (37) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA—Designated
Items (May 2008) ( 42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of
commercially available off-the-shelf items.)
___(ii) Alternate | (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the
acquisition of commercially available off-the-shelf items.)
___ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential
Hydrofluorocarbons (Jun 2016) (E.0. 13693).
___ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air
Conditioners (Jun 2016) (E.0. 13693).
__ (40) (i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.0.s
13423 and 13514).
___ (ii) Alternate | (Oct 2015) of 52.223-13.
___ (41) (i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.0.s 13423 and
13514).
__ (ii) Alternate | (Jun2014) of 52.223-14.
___ (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (May
2020) (42 U.S.C. 8259b).
__ (43) (i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OcT
2015) (E.0.s 13423 and 13514).
___ (ii) Alternate | (JUN 2014) of 52.223-16.
___ (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun
2020) (E.0. 13513).
___ (45) 52.223-20, Aerosols (Jun 2016) (E.0. 13693).
__ (46) 52.223-21, Foams (Jun2016) (E.0. 13693).
__ (47) (i) 52.224-3 Privacy Training (JAN 2017) (5 U.S.C. 552 a).
__ (ii) Alternate | (JAN 2017) of 52.224-3.
__ (48) 52.225-1, Buy American-Supplies (May 2014) (41 U.S.C. chapter 83).
__ (49) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (May
2014) (41 U.S.C.chapter83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19
Contract No. 75N92020C00013 Page 16
U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-
283, 110-138, 112-41, 112-42, and 112-43.
__ (ii) Alternate | (May 2014) of 52.225-3.
__ (iii) Alternate Il (May 2014) of 52.225-3.
___ (iv) Alternate III (May 2014) of 52.225-3.
___ (50) 52.225-5, Trade Agreements (Oct 2019) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).
___ (51) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.’s, proclamations,
and statutes administered by the Office of Foreign Assets Control of the Department of the
Treasury).
___ (52) 52.225-26, Contractors Performing Private Security Functions Outside the United States
(Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal
Year 2008; 10 U.S.C. 2302Note).
___ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov2007) (42 U.S.C. 5150).
___ (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov2007)
(42 U.S.C. 5150).
___ (55) 52.229-12, Tax on Certain Foreign Procurements (JUN 2020).
___ (56) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb
2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).
___ (57) 52.232-30, Installment Payments for Commercial Items (Jan2017)
(41 U.S.C. 4505, 10 U.S.C. 2307(f)).
___ (58) 52.232-33, Payment by Electronic Funds Transfer-System for Award
Management (Oct2018) (31 U.S.C. 3332).
___ (59) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award
Management (Jul 2013) (31 U.S.C. 3332).
___ (60) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).
___ (61) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).
___ (62) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(13)).
___ (63) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (FEB
2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).
___(ii) Alternate | (Apr 2003) of 52.247-64.
__ (iii) Alternate II (Fes 2006) of 52.247-64.
(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial
services, that the Contracting Officer has indicated as being incorporated in this contract by
reference to implement provisions of law or Executive orders applicable to acquisitions of
commercial items:
[Contracting Officer check as appropriate.)
__ (1) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter67).
___ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May
2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).
___ (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price
Adjustment (Multiple Year and Option Contracts) (Aug
2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).
__ (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price
Adjustment (May 2014) ( 29U.S.C.206 and 41 U.S.C. chapter 67).
___(5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to
Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May
2014) (41 U.S.C. chapter 67).
___ (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to
Contract No. 75N92020C00013 Page 17
Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67).
___(7) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).
___ (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.0. 13706).
___ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020)
(42 U.S.C. 1792).
(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of
this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the
simplified acquisition threshold, as defined in FAR 2.101, on the date of award of this contract,
and does not contain the clause at 52.215-2, Audit and Records-Negotiation.
(1) The Comptroller General of the United States, or an authorized representative of the
Comptroller General, shall have access to and right to examine any of the Contractor’s
directly pertinent records involving transactions related to this contract.
(2) The Contractor shall make available at its offices at all reasonable times the records,
materials, and other evidence for examination, audit, or reproduction, until 3 years after
final payment under this contract or for any shorter period specified in FAR subpart 4.7,
Contractor Records Retention, of the other clauses of this contract. If this contract is
completely or partially terminated, the records relating to the work terminated shall be
made available for 3 years after any resulting final termination settlement. Records relating
to appeals under the disputes clause or to litigation or the settlement of claims arising under
or relating to this contract shall be made available until such appeals, litigation, or claims are
finally resolved.
(3) As used in this clause, records include books, documents, accounting procedures and
practices, and other data, regardless of type and regardless of form. This does not require
the Contractor to create or maintain any record that the Contractor does not maintain in
the ordinary course of business or pursuant to a provision of law.
(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this
clause, the Contractor is not required to flow down any FAR clause, other than those in this
paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the
extent of the flow down shall be as required by the clause-
(i) 52.203-13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509).
(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or
Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further
Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in
subsequent appropriations acts (and as extended in continuing resolutions)).
(iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or
Provided by Kaspersky Lab and Other Covered Entities (JUL 2018) (Section 1634 of Pub. L.
115-91).
(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video
Surveillance Services or Equipment. (AUG 2019) (Section 889(a)(1)(A) of Pub. L. 115-232).
(v) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)), in
all subcontracts that offer further subcontracting opportunities. If the subcontract (except
subcontracts to small business concerns) exceeds the applicable threshold specified in
FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219-
8 in lower tier subcontracts that offer subcontracting opportunities.
Contract No. 75N92020C00013 Page 18
(vi) 52.222-21, Prohibition of Segregated Facilities (APR 2015).
(vii) 52.222-26, Equal Opportunity (Sep 2015) (E.0.11246).
(viii) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).
(ix) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).
(x) 52.222-37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).
(xi) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC
2010) (E.0. 13496). Flow down required in accordance with paragraph (f) of FAR
clause 52.222-40.
(xii) 52.222-41, Service Contract Labor Standards (Aug2018) (41 U.S.C. chapter 67).
(xiii) (A) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.O
13627).
(B) Alternate | (Mar2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).
(xiv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to
Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements
(May2014) (41 U.S.C. chapter 67).
(xv) 52.222-53, Exemption from Application of the Service Contract Labor Standards to
Contracts for Certain Services-Requirements (MAY2014) (41 U.S.C. chapter 67).
(xvi) 52.222-54, Employment Eligibility Verification (Oct 2015) (E.O. 12989).
(xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).
(xviii) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).
(xix) (A) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).
(B) Alternate | (Jan 2017) of 52.224-3.
(xx) 52.225-26, Contractors Performing Private Security Functions Outside the United
States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for
Fiscal Year 2008; 10 U.S.C. 2302 Note).
(xxi) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun
2020) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR
clause 52.226-6.
(xxii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb
2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance
with paragraph (d) of FAR clause 52.247-64.
(2) While not required, the Contractor may include in its subcontracts for commercial items a
minimal number of additional clauses necessary to satisfy its contractual obligations.
(End of clause)
PART Ill - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS SECTION J LIST OF ATTACHMENTS
1. Statement of Objectives
2. Contract Deliverables
3. Draft Performance Work Statement
Contract No. 75N92020C00013 Page 19
Attachment 3 — Statement of Objectives RADx ATP POC
Statement of Objectives
Title: RADx ATP - Accelerated Manufacturing Scale-Up of Rapid Point-of-Care Antigen Tests for
COVID-19 Diagnosis
Agency: National Institutes of Health (NIH)
1. Background
The National Institutes of Health (NIH), through the National Institute of Biomedical Imaging
and Bioengineering (NIBIB) has a requirement which will provide up to $230M across multiple
projects to rapidly produce innovative SARS-CoV-2 diagnostic tests that will assist the public’s
safe return to normal activities. Rapid Acceleration of Diagnostics (RADx), is a fast-track
technology development program that leverages the NIH Point-of-Care Technology Research
Network (POCTRN). RADx will support novel solutions that build the U.S. capacity for SARS-
CoV-2 testing up to 100-fold above what is achievable with standard approaches. RADx is
structured to deliver innovative testing strategies to the public as soon as late summer 2020
and is an accelerated and comprehensive multi-pronged effort by NIH to make SARS-CoV-2
testing readily available to every American.
2. Purpose and Objectives
RADx Advanced Technology Platforms (RADx-ATP) will increase testing capacity and
throughput by identifying and supporting existing and late stage testing platforms for
detecting SARS-CoV-2, the virus that causes COVID-19, that are far enough advanced to
achieve rapid scale-up and/or expanded geographical placement in a short amount of time.
Through RADx ATP, NIH aims to increase capacity and optimize throughput for point-of-care
(POC) testing platforms and high-throughput laboratories. To ensure that increased
availability of advanced technology platforms are available to the public as quickly as possible,
NIH will leverage established partnerships with federal agencies, such as FDA, CDC, CMS,
ASPR/BARDA, the Department of Defense, as well as commercial and private entities to propel
technologies developed by RADx into widespread use.
The RADx-ATP program will focus on scaling up technologies, including improving existing
point of care and high-throughput platforms, to increase testing (i.e. detection) performance
and increase the nation’s testing capacity by one million tests per day.
Specifically RADx-ATP seeks to:
e Commercialize and scale production of existing technologies that are already or near
FDA authorization for SARS-CoV-2 detection.
Establish or expand regional testing hubs, to validate and perform clinical tests.
Identify and support the resource needs to expand testing in underserved populations.
Facilitate the development of tests capable of differentiating SARS-CoV-2 vs. Influenza
virus detection.
e Accelerate the development and implementation of tests for other infectious
Page 1 of 5
Attachment 3 — Statement of Objectives RADx ATP POC
pathogens.
For RADx-ATP-funded Point-of-Care test providers, the key objectives include the ability to
manufacture between 20-000 and 100,000 SARS-CoV-2 tests/day by September 1st, 2020; the
ability to obtain and maintain required regulatory approvals/EUAs; the ability to scale up
production and facilities to meet additional demand; ability to deploy testing in underserved, hard-
to-reach communities; existing or planned (within 12 months) capacity for using FHIR-based APIs to
electronically transmit data; development and execution of a robust plan to continuously collect
post-market data to support a PMA/510(k) submission, share data with the NIH, and monitor
variables that may impact test results; and competitive cost per test. This initiative aims to increase
the ability for widespread diagnostic testing of the public to enable reopening and monitoring of
industrial, educational and public sectors.
3. Scope
Funding for projects at an advanced stage of readiness (referred to as Phase Two or Work Package
Two) will cover the full range of activities needed to increase capacity and optimize throughput
necessary to distribute a viable product to the public. Supported by a RADx expert consulting team,
NIH will provide milestone-driven financial and in-kind resources to maximally accelerate progress.
NIH will closely monitor progress, assess milestone achievements, and evaluate the need for
continued funding. Scope of work executed under this contract, includes completing the validation,
approval, and production processes in order to deliver a viable product in a scaled-up capacity to
the U.S. public.
4. Performance Objectives (Required Results)
e The contractor must have the capacity to scale production to between si
units of Sofia SARS Antigen FIA tests (hereto “product”) per day by June 30, 2021, in
accordance with the deliverables schedule defined below.
e The product must have and maintain a minimum of 90% sensitivity and 95% specificity.
e The contractor must share all FDA correspondence (to and from the FDA) regarding the
regulatory submission and feedback of the product and the Sofia Influenza A+B/SARS FIA
test, and invite the NIH to attend meetings with FDA regarding the product and the Sofia
Influenza A+B/SARS FIA test.
e The contractor must make the product and other tests that concurrently detect Influenza
A&B available for independent regulatory/validation assessment.
e The contractor must provide within two weeks a deployment/placement strategy for rapidly
deploying the product to Point-of-Care settings. The contractor must provide updates to the
deployment/placement strategy as needed to accommodate increased output and/or
changes in demand.
e The contractor must, within two weeks of the award of the letter contract, provide a
detailed plan to address supply chain shortage issues and related delays, and must provide
updates to this plan, as appropriate.
e The contractor must prove existing capability for using FHIR-based APIs for standardized
Page 2 of 5
Attachment 3 — Statement of Objectives RADx ATP POC
electronic data transmission within one month of the ratification of the letter contract. If
such capability is lacking, the contractor must, within one month of award of the letter
contract, present a plan for implementing such capability within two months of letter
contract ratification.
The contractor should have the ability to test concurrently for Influenza A&B.
The contractor must have the ability to pe
pe lwith special focus on ease-of-use (including specimen collection mode, clear
and easy to understand instructions to facilitate widespread uptake).
The contractor must, within two weeks of award of the letter contract, submit a robust plan
to continuously collect post-market data to support a PMA/510(k) submission; share data
with NIH; update clinical validity measures; and monitor differences in test results by type
of specimen, collection device, user, setting, and other variables that may impact test
results.
The contractor must, within three weeks of award of the letter contract, provide a risk
mitigation plan for each identified risk and update and inform NIH on any changes/newly
identified risks in an ongoing manner.
The contractor must meet regularly (at least weekly) with NIH officials to update on
progress toward deliverables; anticipated and ongoing issues and problems; and timelines
for deliverable completion.
When guided by NIH officials, the contractor must be willing to collaborate and cooperate
with external organizations as needed to meet the contract goals in a manner which will not
infringe contractor commercial or intellectual property rights.
Any imported materials must be FDA-approved for use in the US.
In consideration for the investment in manufacturing scale-up, the contractor must make
available between[™” ____—_—_—_ofia SARS FIA Antigen tests and|”
Sofia/Sofia2 Analyzers during the period of performance.
5. Contract Type
Firm Fixed Price
6. Place of Performance
Quidel Corporation
9975 Summers Ridge Rd
San Diego, CA, 92121-2997
UNITED STATES
7. Period of Performance
The period of performance is anticipated to be July 30, 2020 — July 29, 2021.
8. Deliverables/Delivery Schedule
Deliverables will be developed specific to each contract awarded. Below is an example of the types
Page 3 of 5
Attachment 3 — Statement of Objectives RADx ATP POC
of categories of deliverables that would be provided under RADx ATP contracts.
‘TaskNo. Deliverable Title
1
la
1.b
1c
3.f
Program Management
Risk Management Plan
Recurring reports (inclusive of scale up progress, challenges, status
of management of adequate supply chain, current production
capacity)
Detailed plan to address supply chain shortages and related
delays, followed by updates to this plan, as appropriate
Scale-Up and Deployment Plan
Final plan/approach and timeline for manufactu:
modifications to meet scale-up requirements of
SARS Antigen FIA tests per day by June 30, 2021
ring line
Poti
Hire and train personnel to support scale up plan
Final plan/approach for rapidly deploying the product to Point-of-
Care settings
Regulatory and external testing
Report on the results of clinical/EUA validation studies of the
combined Sofia Influenza A+B/SARS FIA test
Documentation of regulatory approval for combined Sofia
Influenza A+B/SARS FIA test
Plan to collect post-market data to support a PMA/510(k)
submission; share data with NIH; update clinical validity measures;
and monitor differences in test results by type of specimen,
collection device, user setting, and other variables that may impact
test performance/results
Report on the plan to collect post-market data as described in 3.e
Space renovation/construction and Manufacturing
Report on the submission of permits for space
renovation/construction, as appropriate
Documentation of completed and passed inspections for
renovated/constructed space, as appropriate
Final engineering drawings and environmental control
specifications completed for renovated/constructed space
Quotes from vendors and documentation of orders for equipment
for additional/modified production lines
Report of completed space renovation and/or construction, and
installation of equipment for increasing production capacity
Report on the completion of debugging, validation and safety
studies of new equipment/assembly/production lines; implement
a quality management system
Page 4 of 5
Due Date
8/21/20
weekly
8/14/20, updated as
necessary
8/10/20
According to plan in 2.a
8/14/20
10/31/20
11/30/20
8/14/20
monthly
8/10/20
According to plan in 2.a
According to plan in 2.a
According to plan in 2.a
According to plan in 2.a
According to plan in 2.a
Attachment 3 — Statement of Objectives RADx ATP POC
Demonstration of Scaled Manufacturing Production
Report on the demonstration of increased capacity
SARS Antigen FIA tests/day
Report on the demonstration of increased capacity t
SARS Antigen FIA tests/day
Report on the demonstration of increased capacity
SARS Antigen FIA tests/day
Report on the demonstration of increased capacity i; a
SARS Antigen FIA tests/day
Report on the demonstration of increased capacity t
SARS Antigen FIA tests/day
Report on the demonstration of increased capacity
Analyzers per month
Report on the demonstrated capability for using FHIR-based
APIs for standardized electronic data transmission, or a plan
for implementing such a capability within two months of
letter contract ratification.
Sustained supply chain and production capacity plan for the Sofia
SARS Antigen FIA test and Sofia Analyzer
Other Requirements
8/31/20
12/31/20
3/31/21
5/15/21
6/30/21
12/31/20
8/31/20
12/31/21
1) Data Sharing: NIH policy promotes data sharing to allow scientists to expedite the translation of
research results into products and procedures to improve human health. Sharing data reinforces open
scientific inquiry, encourages diversity of analysis and opinion, promotes new research, makes possible
the testing of new or alternative hypotheses and methods of analysis, supports studies on data
collection methods and measurement, facilitates the education of new researchers, enables the
exploration of topics not envisioned by the initial investigators, and permits the creation of new datasets
when data from multiple sources are combined.
Page 5 of 5
No. Objective Defined ‘Success Criteria Deliverable Due Date|
1 [Risk awareness and Risk mitigation plan 1a. Risk mitigation plan Provide to NIH a thorough list of identified risks] 8/5/2020
management plus details on mitigation strategies.
2 [Recurring progress reports __ | Weekly progress report fib. weekly reports [Meetings and/or documents submitted to the weekly
INIH to update progress toward deliverables;
anticipated and ongoing issues and problems;
and timelines for deliverable completion.
3. [Supply chain management __|Supply chain management plan |1.c Detailed plan to address _| A plan to manage adequate supply of 8/14/2020
supply chain shortages and _| consumable, reagents, and other equipment
related delays; updates to this over the course of the scale up plan. The plan
plan as appropriate should clearly identify the
|consumable/equipment name/category,
specifications, manufacturer, catalog number,
|quantity needed by critical dates, possible
substitutions, existing or possible solution for
lobtaining the needed supply
4 |Scale-up plan Final plan/approach and 2.2 Final plan/approach and __ [Detailed plan with the final approach to 8/5/2020
timeline for manufacturing _|timeline for manufacturing line _|renovations/construction to meet the scale-up
modifications modifications to meet scale-up requirements, inclusive of a timeline for
requirements oftis)_ ote |developing engineering diagrams; defining
ISARS Antigen FlATests per day environmental control specifications; obtaining
permits and inspections required; obtaining
Jquotes from vendors for equipment; placing
lorders; installation of equipment; space
Irenovation/construction; debugging, validation
and safety studies for the new/retrofitting
[production and assembly lines; and
implementation of a quality management
system
5 [Scale-up plan Hire and train personnel 2.b Hire and train personnel __|Labor resources in place to carry out the scale- | according to timeline
lup plan and demonstration of increased in deliverable 2.
6 [Deployment plan Deployment plan 2.c Final plan/approach for __|Clear description of the plan and process to 8/14/2020
rapidly deploying the product to |rapidly deploy the product to point-of-care
Point-of-Care settings settings
‘ht [Regulatory and external testing |Clinical/EUA validation studies |3.c Report on the results of |__| Report on the results of the clinical study that 10/31/2020
lof the combined Sofia Influenza |clinical/EUA validation studies of |includes sample size and performance metrics
|A+B/SARS FIA test the combined Sofia Influenza __|met for EUA submission to FDA
|A+B/SARS FIA test
‘iti [Regulatory and external testing [Regulatory approval for 3.d Documentation of regulatory |FDA EUA for the combined Sofia Influenza 11/30/2020
Icombined Sofia Influenza approval for combined Sofia A+B/SARS FIA test.
|A+B/SARS FIA test Influenza A+8/SARS FIA test
Regulatory and external testing [Plan for longer term data 3.e Plan to collect post-market [Data collection in support of a submission 8/14/2020
collection and evaluation Jdata to support a PMA/S10{k) _|toward a PMA/510(k) from the FDA; sharing de-
submission; share data with NIH; identified data according to a plan agreed upon
lupdate clinical validity measures; with NIH; continuous evaluation of variables
Jand monitor differences in test |that may impact test performance (e.g. type of
results by type of specimen, _| specimen, collection device, user setting)
collection device, user setting,
land other variables that may
impact test performance/results
Regulatory and external testing Implementation of the plan for_|3.f Report on the plan to collect |Written report on the implementation of the monthly
longer term data collection and |post-market data as described in |plan to collect post-market data as described in
evaluation 3.e 3.e
‘Witt [Space renovation/construction [Permits [41a Report on the submission of |Necessary permits are submitted to the 8/10/2020
jand Manufacturing permits for space appropriate administrative bodies for space
renovation/construction, as __|renovation/construction
appropriate
‘ti [Space renovation/construction [Inspections [a,b Documentation of [Necessary inspections are completed according to timeline
jand Manufacturing lcompleted and passed successfully for renovated/constructed space | in deliverable 2.a
inspections for
renovated/constructed space, as
‘itis |Space renovation/construction |Renovation/construction plans |4.c Final engineering drawings _ |Renovation/construction plans complete that _| according to timeline
land Manufacturing
land environmental control
specifications completed for
renovated/constructed space
define space/layout and environmental control
specifications
deliverable 2.a
Production
[Standardized electronic data
transmission
[Capability or plan for
[standardized electronic data
transmission
Sofia Analyzers per month
[6. Report on the demonstrated
[capability for using FHIR-based
|APIs for standardized electronic
Jdata transmission, or a plan for
implementing such a capability
lover a period not to exceed 12
months
74 Space renovation/construction [Quotes and orders for [ad Quotes from vendors and _ Orders placed with selected vendors for according to timeline
jand Manufacturing lequipment Jdocumentation of orders for __Jequipment/components necessary for in deliverable 2.a
lequipment for Inew/modified production lines
|additional/modified production
lines
15 [Space renovation/construction [Space renovation/construction |4.e Report of completed space [Complete space renovation/construction and | according to timeline
jand Manufacturing land installation of equipment _ renovation and/or construction, |installation of equipment in deliverable 2.2
and installation of equipment for
increasing production capacity
16 [Space Renovation/construction [Debug, validate, and perform _|4f. Report on the debugging, _ |New equipment and assembly/production lines | according to timeline
jand Manufacturing safety studies validation and safety studies of |are debugged/studied/validated to the level of | in deliverable 2.2
new performance of existing Sofia SARS Antigen FIA
|equipment/assembly/production| test manufacturing
lines
17 Scaled Manufacturing [Scale-up manufacturing 5.a Report on the demonstration | Production of increased capacity ofa Fate 8/31/2020
Production lof increased capacity tof>X4) SARS Antigen FIA tests/day
18 [Scaled Manufacturing [Scale-up manufacturit 5.b Report on the demonstration] Production of increased capacity to[)ofia 12/31/2020
Production ARs Antigen FIA tests/day
Scaled Manufacturing Scale-up manufacturing tion Production of increased capacity tof) Pofia 3/31/2021
Production ISARS Antigen FIA tests/day
Sofia SARS Antigen FIA tests/day
20 [Scaled Manufacturing [Scale-up manufacturing [5.d Report on the demonstration | Production of increased capacity tof" oa 5/15/2021
Production lof increased capacity tofOX4) __ BARS Antigen FIA tests/day
21 [Scaled Manufacturing [Scale-up manufacturing [5.e Report on the demonstration | Production of increased capacity wD fora 6/30/2021
Production ISARS Antigen FIA tests/day
22 |Scaled Manufacturing scale-up manufacturing 5. Report on the demonstration [Production of increased capacity oppor 77/31/2020
[Capability or plan for using FHIR-based APIs for
the standardized electronic data transmission
lof results to patients, providers and public
health authorities and receipt of order from
provider, with ability to integrate digital
software from test prescription to transmission
lof results. Where applicable, such FHIR-based
|APIs should meet implementation
specifications outlined by the Office of the
National Coordinator for Health Information
Technology in the 21st Century Cures Act final
rule (published in the Federal Register on
16/1/2020), meet HHS requirements on
laboratory data reporting released on
16/4/2020, disclose the unique device
identifier(s) associated with the diagnostic, and
Juse LOINC for communicating laboratory
lobservations. Consult
https://www.healthit.gov/curesrule/ for most
recent updates
8/31/2020
24 [Sustainability plan
Sustained supply chain and
production capacity plan
7. Sustained supply chain and
production capacity plan for the
Sofia SARS Antigen FIA test and
Sofia Analyzer
The plan clearly describes how the supply chain
[and production capacity will be sustained to
Imeet the demands of SARS-CoV-2 testing
12/31/2021
SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS
OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30
7” REQUISITION NUMBER PAGE OF
5766209 1 21
2 CONTRACT NO, 3, AWARO/ Js. ORDER NUMBER 5. SOLICITATION NUMBER Is. SOLICITATION
75N92020C00014 EFFECTIVE DATE ISSUE DATE
07/30/2020
7. FOR SOLICITATION fa. NAME jp TELEPHONE NUMBER (No colect call) JB. OFFER DUE DATE/LOCAL TINE
INFORMATION CALL: INATALIE BRUNING +1 301 827 7528
‘9. ISSUED BY cove [NHLBI 10. THISACQUISITIONIS _X — UNRESTRICTEDOR SET ASIDE: % FOR:
F WOMEN-OWNED SMALL BUSINESS
Natalie Bruning ‘SMALL BUSINESS (WOSB) ELIGIBLE UNDER THE WOMEN-OWNED
NIH/NHLBI HUBZONE SMALL sree aA Mc naics:334516
6701 Rockledge Dr SuSHESS: ENV:
RKL II, Rm 6110 Souauicinee. al size stanoaro: 1,000
Bethesda, MD 20892-7511 SMALL BUSINESS
V7, DELIVERY FOR FOB DESTINA. _[}2. DISCOUNT TERMS 3b, RATING
TION UNLESS BLOCK IS 13a, THIS CONTRACT ISA
MARKED RATED ORDER UNDER
pasa eae rare omens EOD OF SOUETATOR
75. DELVERTO COoE ppp, BTHOFF 16, ADMINISTERED BY CODE NIBIB
Two Democracy Plaza, Bethesda Off C Michael Wolfson
2 Democracy Plaza INIH/NIBIB
6707 Democracy Blvd 6707 Democracy Blvd
Bethesda MD 20817 DEM II, Rm 200
Bethesda, MD 20892-7511
Tia CONTRACTOR ‘CODE FAGRTY "aa. PAYMENT WILL BE MADE BY COOE [NHLBI INV-BR-A
MESA TECH INTERNATIONAL INC:1186920
Attn: Ingo Chakravarty
6190 CORNERSTONE CT E
SUITE 220
SAN DIEGO CA 92121-4701
858-692-9870
[Approved By, NHLBI Branch A Invoice
Paid By: NIH Commercial Accounts Br
2115 East Jefferson St, MSC 8500
Room 4B-432
Bethesda, MD 20892-8500
‘TELEPHONE NO,
170, CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER [1ab. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW
IS CHECKED ‘SEE ADDENDUM
19, 20. 2 22. 23. 24,
ITEM NO, ‘SCHEDULE OF SUPPLIESISERVICES QUANTITY |UNIT UNIT PRICE AMOUNT
Easy To Use,
test, Highly Scalable
Rapid Acceleration of Diagnostics (RADx)
Itech Project #2244 Mesa Biotech, Inc.
Period of Performance:
qi IRADx Tech Project #2244 - Mesa - Critical design
Continued ...
(Use Reverse and/or Attach Additional Sheets as Necessary)
25. ACCOUNTING AND APPROPRIATION DATA
See schedule
Low-Cost Molecular-Based SARS-CoV-2
Program:
07/30/2020 to 07/29/2021
TOTAL AWARD AMOUNT (For Govt. Use Only)
$4,991, 604.00
27a, SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, §2.212-4. FAR 52.2123 AND 52212-5 ARE ATTACHED. ADDENDA ARE | ARE NOT ATTACHED.
X 27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4, FAR 52.212-5 IS ATTACHED. ADDENDA X ARE ARE NOT ATTACHED,
29. AWARD OF CONTRACT: OFFER
28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN
COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER
ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL
SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.
DATED YOUR OFFER ON SOLICITATION (BLOCK 5),
INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH
HEREIN, IS ACCEPTED AS TO ITEMS:
‘30a, SIGNATURE OF OF FERORIGONTRAPD)G)
Bia, UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)
; ; Digitally signed by Allison M. Cristman -S
Allison M. Cristman -S Date: 2020.07.30 12:51:51 -04'00"
\TE SIGNED
July 30, 2020
30b, NAME AND TITLE OF SIGNER (Type or print)
Ingo Chakravarty, President & CEO
[31c. DATE SIGNED
07/30/2020
[31b. NAME OF CONTRACTING OFFICER (Type or print)
[ALLISON M. CRISTMAN
AUTHORIZED FOR LOCAL REPRODUCTION
PREVIOUS EDITION IS NOT USABLE
‘STANDARD FORM 1449 (REV. 2/2012)
Prescribed by GSA - FAR (48 CFR) 53.212
19, 20. 21 22. 23. 24
ITEM NO, ‘SCHEDULE OF SUPPLIESISERVICES. ‘quantiry | UNIT UNIT PRICE AMOUNT
review and risk analysis
Obligated Amount
Delivery To: Bldg.31/RM IC31
Product/Service Code: Q301
Product/Service Description: MEDICAL- LABORATORY
TESTING
Delivery: 08/03/2020
Project Data:
151201.2020.300.COVID-19.DIAG.HN81 NIBIB OD
OFFICE OF THE DIRECTOR.25235 ALL OTHER NON-FED
SERVCS .07/29/2020
Accounting Info:
08039820200DAD. 2020.83.8100.EM81000000C.E.C4400. 40
6.COVD.25235.61000001.9999.9999.9999
fiona)
implementation plan
Obligated Amount:P™_ Cid
Delivery To: Bldg.31/RM 1C31
Product/Service Code: 301
Product/Service Description: MEDICAL- LABORATORY
TESTING
Delivery: 08/17/2020
Project Data:
Continued ...
32a, QUANTITY IN COLUMN 21 HAS BEEN
RECEIVED INSPECTED ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:
32b, SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32c. DATE 3
RINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE
32e, MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE
32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE
33. SHIP NUMBER [35. AMOUNT VERIFIED 36. PAYMENT
CORRECT FOR
39. SIR VOUCHER NUMBER
41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT.
41b, SIGNATURE AND TITLE OF CERTIFYING OFFICER
37. CHECK NUMBER
COMPLETE
PARTIAL
PARTIAL FINAL
38, SIR ACCOUNT NUMBER 40. PAID BY
|42a. RECEIVED BY (Print)
1c. DATE
42b. RECEIVED AT (Location)
l42c. DATE REC'D (YY/MM/DD)
42d, TOTAL CONTAINERS
‘STANDARD FORM 1449 (REV. 2/2012) BACK
CONTINUATION SHEET
NAME OF OFFEROR OR CONTRACTOR
MESA TECH INTERNATIONAL INC:1186920
ITEM No SUPPLIES'SERVICES QUANTITY UNIT ——_UNITPRICE AMOUNT
(A) (B) (cy) (D) (E) (F)
151201.2020.300.COVID-19.DIAG.HN81 NIBIB OD
OFFICE OF THE DIRECTOR.25235 ALL OTHER NON-FED
SERVCS.07/29/2020
Accounting Info:
08039820200DAD. 2020.83.8100.EM81000000C.E.C4400.40
6 .COVD. 25235. 61000001. 9999. 9999.9999
Punded:
3 RADx Tech Project #2244 - Mesa - Phase 1 of
Semi-automated production plan
Obligated Amount :{?
Delivery To: Bldg.31/RM 1C31
Product/Service Code: Q301
Product/Service Description: MEDICAL- LABORATORY
TESTING
Delivery: 08/31/2020
Project Data:
151201.2020.300.COVID-19.DIAG.HN81 NIBIB OD
OFFICE OF THE DIRECTOR.25235 ALL OTHER NON-FED
SERVCS .07/29/2020
Accounting Info:
08039820200DAD.2020.83.8100.EM81000000C.E.C4400.40
6 .COVD. 25235. 61000001. 9999.9999.9999
NSN 7540-01-152-8067 ‘OPTIONAL FORM 336 (4-86)
‘Sponsored by GSA
FAR (48 CFR) 53.110
PART | — THE SCHEDULE
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
ARTICLE B.1. BRIEF DESCRIPTION OF SERVICES
This Letter Contract forms a preliminary understanding between Mesa Biotech, Inc. (Mesa) and the National
Institutes of Health (NIH) and is issued as a result of the Rapid Acceleration of Diagnostics Tech (RADx-Tech) to
increase the testing capacity of high throughput labs by scaling up late stage testing platforms for detecting
SARS-CoV-2, the virus that causes COVID-19. Issuance of this Letter Contract authorizes the Contractor to
immediately begin the activities necessary to perform the requirements as identified in the Statement of
Objectives covering the full range of activities needed to increase capacity and optimize throughput necessary to
distribute a viable product to the public.
Mesa has developed an Easy to Use, Low-Cost Molecular-Based SARS-CoV-2 Test, Highly Scalable. The Accula
SARS-CoV-2 test kit is a single-use molecular diagnostic test utilizing PCR and lateral flow technologies for the
qualitative, visual detection of coronavirus SARS-CoV-2 viral RNA. The scope of work executed under this
contract, includes completing the validation, approval, and production processes in order to deliver a viable
product in a scaled up capacity to the U.S. public.
This Letter Contract has been issued based on the application and preliminary work file submitted by the
contractor and subsequent documentation submitted during the Point of Care Technology Research Network
(POCTRN) application review process. The Contractor’s inability to meet the requirements as defined within this
Letter Contract and proposed within the POCTRN application process may result in the termination of the Letter
Contract in accordance with the termination clauses contained herein.
ARTICLE B.2. PRICES
a. The total Firm Fixed Price (FFP) amount for the Letter Contract is $5,991,604.
Payment Schedule
Milestone Amount
Complete critical design review (CDR) and
risk analysis to finalize design of semi-
automated line
Finalize semi-automated implementation
plan; maintain production capacity of |
a |
Complete first phase of semi-automated
production plan; maintain production
capacity of PO
b. The parties agree to negotiate Options for additional work during the definitization of the contact.
Contract number 75N92020C00014 Page 4
ARTICLE B.3. ADVANCE UNDERSTANDINGS
a. The parties acknowledge and agree that the situation around COVID-19 is highly dynamic, evolving
rapidly, and subject to significant uncertainty. The Letter Contract is being executed on an expedited
timeline to meet an urgent and compelling government need without the benefit of prior negotiation.
Thus, the parties will negotiate in good faith to ensure that the definitized contract reflects an
appropriate allocation of risk and responsibility and that it is consistent with the application and
preliminary work file submitted by the contractor and subsequent documentation submitted during the
application review process and the discussions between the parties that have taken place between date
of application submission through Letter Contract issuance. Until the Performance Work Statement
(PWS) is finalized the Statement of Objective (SOO) will govern.
b. Funding in the amount not to exceed $5,991,604 is made available under this letter contract. The
contractor shall not incur costs in excess of this amount.
c. The parties anticipate that the definitive contract resulting from this Letter Contract will ii
negotiated firm fixed price not to exceed?’ | ind an option value not to exce!
a total price including all options not to exceed 6,704.
d. Commercial Item Status: The services provided by the Contractor under the Letter Contract and any
definitized contract constitute commercial item services, and the terms of any definitized contract will
reflect that understanding.
e, Performance Work Statement: The parties will negotiate the Performance Work Statement in the
process of contract definitization to fairly reflect the application and preliminary work file submitted by
the contractor and subsequent documentation submitted during the application review process and the
discussions between the parties that have taken place between application submission through letter
contract issuance.
f. HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to
include rating this order in accordance with 45 CFR Part 101, Subpart A—Health Resources Priorities and
Allocations System.
g. The parties agree prior to negotiate further the terms of milestone payments to include in the
definitized contract. In the negotiation, the parties will consider terms addressing liquidation of
milestone payments.
h. Successful performance under this contract requires the Contractor obtain and maintain an Emergency
Use Authorization (EUA) from the Food and Drug Administration (FDA); the Contractor shall copy us on
all FDA correspondence related to the project, including email communications to and from the FDA.
The FDA EUA services provided under this Letter Contract constitute a commercial service to detect
SARS-CoV-2.
i. Fair Pricing: The Rapid Acceleration of Diagnostics (RADx) application review process determined the
cost per test is competitive with the current market price. The Contractor must comply with applicable
federal law to ensure that prices to consumers are offered at fair market rate and at a rate consistent
with the objective to increase and improve testing in the United States.
Contract number 75N92020C00014 Page 5S
j. In accordance with the goals of the RADx program, the tests produced under this contract are to be sold
within the U.S. and its territories; provided, however, that, to the extent there is insufficient demand
within the U.S. and its territories for the tests produced up to the additional manufacturing capacity
funded by NIH and then available (as described in the Schedule of Deliverables), contractor will be
permitted to sell such tests outside the U.S. and its territories. The factors, process and mechanism to
determine whether contractor has insufficient demand for the tests up to the then-available capacity
will be determined in the definitive contract.
k. Sharing Data and Reports: The Contractor will be required to provide data and reports (e.g.,
manufacturing, supply chain, production rates), which NIH will use to evaluate completion or
achievement of milestones, progress toward deliverables, and compliance with the requirements of this
Letter Contract. NIH may use the data to coordinate with other U.S. Government Agencies to accelerate
development and deployment of innovative COVID-19 diagnostic tests, and ensure effective stewardship
of federal funds. Sharing data within the federal government enables NIH to discuss the project’s
challenges and progress with federal agencies offering scientific, manufacturing, and logistics expertise.
To ensure that innovations are available to the public as quickly as possible, NIH will leverage
established partnerships with federal agencies, such as FDA, CDC, CMS, ASPR/BARDA, and the
Department of Defense, and partnerships with State agencies to propel technologies developed by RADx
into widespread use.
|. Contractor Facilities: The contractor shall certify that they will maintain their Facility and Equipment in
satisfactory operating condition, as required to enable the contractor to perform the deliverables and
achieve the milestones in accordance with the Statement of Objectives and all other applicable laws,
regulations, rules or orders. Routine repairs, preventive maintenance, and service contracts for the
Facility and Equipment shall be arranged by contractor at no additional cost to the Government.
m. Letter Contract Termination: In accordance with 52.212-4(I), the Government reserves the right to
terminate this contract, or any part hereof, for its sole convenience. In the event of such termination,
the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its
suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be
paid a percentage of the contract price reflecting the percentage of the work performed prior to the
notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the
Government using its standard record keeping system, have resulted from the termination. The
Contractor shall not be required to comply with the cost accounting standards or contract cost principles
for this purpose. This paragraph does not give the Government any right to audit the Contractor's
records. The Contractor shall not be paid for any work performed or costs incurred which reasonably
could have been avoided.
n. Letter Contract Termination: In accordance with FAR 52.212-4(m), the Government may terminate this
contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor
fails to comply with any contract terms and conditions, or fails to provide the Government, upon
request, with adequate assurances of future performance. In the event of termination for cause, the
Government shall not be liable to the Contractor for any amount for supplies or services not accepted,
and the Contractor shall be liable to the Government for any and all rights and remedies provided by
law. If it is determined that the Government improperly terminated this contract for default, such
termination shall be deemed a termination for convenience.
Contract number 75N92020C00014 Page 6
o. Security and Privacy of Protected Health Information (PHI) processed under this contract: In the event
that the Contractor meets the definition of either a Covered Entity or Business Associate under the
Health Insurance Portability and Accountability Act of 1996 (HIPAA), the contractor shall comply with
the HIPAA regulatory standards set forth in the Code of Federal Regulations (CFR) 45 C.F.R. Part 160,
Part 162, and Part 164. To the extent that the Contractor engages subcontractors or other Business
Associates to provide services under this Contract, and such Subcontractors or Business Associates will
receive or create protected health information (PHI) on behalf of the contractor, the contractor shall
obtain satisfactory assurances from its business associate that the business associate will appropriately
safeguard the protected health information. The satisfactory assurances must be in writing, whether in
the form of a contract or other agreement between the Contractor and the business associate. In the
event of a suspected or known security or privacy breach, in addition to following the procedures set
forth in 45 C.F.R. Part 164, the contractor shall also immediately notify the NIH via the Contracting
Officer (CO)and the Contracting Officer’s Representative (COR).
p. Any imported materials must be FDA-approved for use in the U.S.
q. The parties agree to address HHS Information Security and Privacy Requirements, as applicable, during
definitization of the contract.
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
ARTICLE C.1, STATEMENT OF OBJECTIVES
Independently and not as an agent of the Government, the Contractor shall furnish all the necessary
services, qualified personnel, material, equipment, and facilities, not otherwise provided by the
Government as needed to perform the Statement of Objectives, dated July 27, 2020, set forth in SECTION
J—List of Attachments, attached hereto and made a part of this Leter Contract. Work to be performed
shall be consistent with the application and preliminary work file submitted by the Contractor and
subsequent documentation submitted during the application review process and the discussions between
the parties that have taken place between date of application submission through Letter Contract
issuance.
ARTICLE C.2. REPORTING REQUIREMENTS
All reports required herein shall be submitted in electronic format only. All electronic reports submitted shall be
compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents
for Section 508 compliance, including guidance and specific checklists, by application, can be found at:
http://www.hhs.gov/web/508/index.htm! under "Making Files Accessible."
Reporting requirements TBD.
Placeholder: De-identified data for NIH research database
SECTION D — PACKAGING, MARKING, AND SHIPPING
There are no additional instructions or specifications applicable to this contract other than the delivery
instructions contained herein.
Contract number 75N92020C00014 Page 7
SECTION E - INSPECTION AND ACCEPTANCE
a. The Contracting Officer or the duly authorized Contracting Officer’s Representative (COR) will perform
inspection and acceptance of deliverables to be performed and the milestones to be achieved.
b. Inspection and acceptance will be performed utilizing the success criteria outlined in the deliverable
schedule.
SECTION F - DELIVERIES OR PERFORMANCE
ARTICLE F.1. PERIOD OF PERFORMANCE
The period of performance of the contract is anticipated to be July 30, 2020 through July 29, 2021.
ARTICLE F.2. DELIVERIES
Satisfactory performance shall be deemed to occur upon performance of the work described in the Statement of
Objectives Article in SECTION C of this Letter Contract and upon notice and acceptance by the Contracting
Officer, or the duly authorized representative, in accordance with the stated deliverables schedule.
The deliverables or documentation thereof shall be submitted to the Contracting Officer or designated
Contracting Officer Representative (COR).
SECTION G - CONTRACT ADMINISTRATION DATA
ARTICLE G.1. CONTRACTING OFFICER (CO)
The following Contracting Officer (CO) will represent the Government for the purpose of
this contract:
Name: Lynn Furtaw
Telephone: 301-827-7713
Email: lynn.furtaw@nih.gov
The Contracting Officer is the only person with authority to act as agent of the Government
under this task order. Only the Contracting Officer has authority to:
1) direct or negotiate any changes in the Satement of Objectives or Performance Work Statement;
2) modify or extend the period of performance;
3) change the deliverables or milestones schedule;
4) authorize reimbursement to the Contractor for any costs incurred during the performance of this
Letter Contract;
5) otherwise change any terms and conditions of this Letter Contract; or
6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in
Section K of this Letter Contract.
All correspondence (including invoices) that proposes or otherwise involves waivers, deviations, or modifications
to requirement shall be provided to the CO issuing this Letter Contract and the COR supporting the CO.
Contract number 75N92020C00014 Page 8
ARTICLE G.2. CONTRACTING OFFICER'S REPRESENTATIVE (COR)
The following Contracting Officer's Representative (COR) is anticipated to represent the Government for
the purpose of this contract:
Olga Hartman, PhD
Telephone: 443-350-7696
Email: olga.hartman.civ@mail.mil
The COR is responsible for:
(1) monitoring the Contractor's technical progress, including the surveillance and assessment of
performance and recommending to the Contracting Officer changes in requirements;
(2) interpreting the Statement of Objectives and any other technical performance requirements;
(3) performing technical evaluation as required;
(4) performing technical inspections and acceptances required by this Letter Contract; and
(5) assisting in the resolution of technical problems encountered during performance.
The Government may unilaterally change the COR designation.
ARTICLE G.3. PRIMARY PROGRAM MANAGER
The Primary Program Manager specified in this contract is considered to be essential to work
performance. At least 30 days prior to any changes to the individual listed below to other programs or
contracts (or as soon as reasonably possible, if an individual must be replaced, for example, as a result of
leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit
comprehensive justification for the change request (including proposed substitutions for primary program
manager) to permit evaluation by the Government of the impact on performance under this contract. The
Contractor shall not replace any primary program manager without the written consent of the Contracting
Officer. The Government may modify the contract to add or delete primary program manager at the
request of the contractor or Government. In no case shall the individual’s effort exceed 100%.
bX)
Primary Program Manager
ARTICLE G.4. INVOICE SUBMISSION
In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include
the following information on the face page of all task order payment requests:
a. The Contract Title is: RADx Tech Mesa 2244 — Easy to Use, Low-Cost Molecular-Based SARS-CoV-2 Test,
Highly Scalable
b. The Contract Line Items are defined within the Section 20. Schedule of Supplies/Services of the Standard
Form 1449.
c. Invoice Instructions are attached and made part of this Letter Contract. The Contractor shall follow the
attached instructions and submission procedures specified below to meet the requirements of a "proper
invoice" pursuant to FAR Subpart 32.9, Prompt Payment.
1. Payment requests shall be submitted to the offices identified below. Do not submit supporting
documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your payment request unless
specified elsewhere in this Letter Contract or requested by the Contracting Officer.
Contract number 75N92020C00014 Page 9
a.
2. E-
One copy of the invoice shall be submitted to the approving official at the following email
addresses:
NHLBI Branch B Central Mailbox (NHLBIContractsBranchB@mail.nih.gov)
NIH centralized invoice email box: invoicing@nih.gov
Mail: The Contractor shall submit an electronic copy of the payment request to the approving official
instead of a paper copy. The payment request shall be transmitted as an attachment via e-mail to the
address listed above in one of the following formats: MSWord, MS Excel, or Adobe Portable
Document Format (PDF). Only one payment request shall be submitted per e-mail and the subject line
of the e-mail shall include the Contractor's name, contract number, and unique invoice number.
3. In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall
include the following information on the face page of all payment requests (invoices):
a.
b.
Name of the Office of Acquisitions. The Office of Acquisitions for this task order is NHLBI.
Central Point of Distribution. For the purpose of this Task Order, the Central Point of Distribution
is NHLBI Branch B Invoices.
Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall
identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number
that appears after the Contractor's name on the face page of the contract. [Note: A VIN is
assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to
include the VIN number.] \f the Contractor has neither a TIN, DUNS, or VIN, contact the
Contracting Officer.
DUNS or DUNS+4 Number. The DUNS number must identify the Contractor's name and address
exactly as stated in the contract and as registered in the Central Contractor Registration (CCR)
database. If the Contractor does not have a valid DUNS number, it shall identify the Vendor
Identification Number (VIN) on the payment request. The VIN is the number that appears after
the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts
awarded on or after June 4, 2007, and any existing contract modified to include the VIN
number.] \f the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.
Invoice Matching Option. This Letter Contract requires a two-way match.
Unique Invoice Number. Each payment request must be identified by a unique invoice number,
which can only be used one time regardless of the number of contracts or orders held by an
organization.
PRISM/NBS Line Item Number and associated PRISM/NBS Line Item Period of Performance (see
Section B — PRICES/OPTION).
d. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-6088.
SECTION H - ADDITONAL CONTRACT CLAUSES
ARTICLE H.1. CONFIDENTIALITY OF INFORMATION
a.
Confidential information, as used in this article, means information or data of a personal
nature about an individual, or proprietary information or data submitted by or pertaining
to an institution or organization.
Contract number 75N92020C00014 Page 10
b. The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this
Letter Contract specific information and/or categories of information which the Government will
furnish to the Contractor or that the Contractor is expected to generate which is confidential.
Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such
confidential information from time to time during the performance of the Letter Contract.
Failure to agree will be settled pursuant to the "Disputes" clause.
c. Ifit is established elsewhere in this Letter Contract that information to be utilized under this
contract, or a portion thereof, is subject to the Privacy Act, the Contractor will follow the rules
and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing
regulations and policies, with respect to systems of records determined to be subject to the
Privacy Act.
d. Confidential information, as defined in paragraph (a) of this article, shall not be disclosed without
the prior written consent of the individual, institution, or organization.
e. Whenever the Contractor is uncertain with regard to the proper handling of material under the
contract, or if the material in question is subject to the Privacy Act or is confidential information
subject to the provisions of this article, the Contractor should obtain a written determination
from the Contracting Officer prior to any release, disclosure, dissemination, or publication.
f. Contracting Officer determinations will reflect the result of internal coordination with
appropriate program and legal officials.
g. The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping
provisions in other Federal, State or local laws.
ARTICLE H.2. PUBLICATION AND PUBLICITY
In addition to the requirements set forth in HHSAR Clause 352.227-70, Publications and Publicity
incorporated by reference in SECTION | of this contract, the Contractor shall acknowledge the
support of the National Institutes of Health whenever publicizing the work under this Letter
Contract in any media by including an acknowledgment substantially as follows:
"This project has been funded in whole or in part with Federal funds from the National Institute
of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health
and Human Services, under Contract No. 75N92020C00014.
ARTICLE H.3. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE
Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in
NIH funded programs is encouraged to report such matters to the HHS Inspector General's Office
in writing or on the Inspector General's Hotline. The toll free number is 1-800-HHS-TIPS (1-800-
447-8477). All telephone calls will be handled confidentially. The website to file a complaint on-
line is: http://oig.hhs.gov/fraud/hotline/ and the mailing address is:
Contract number 75N92020C00014 Page 11
US Department of Health and Human Services Office of Inspector
General
ATTN: OIG HOTLINE OPERATIONS
P.O. Box 23489 Washington, D.C. 20026
PART Il - CONTRACT CLAUSES SECTION | - CONTRACT CLAUSES
ARTICLE 1.1. ADDITIONAL CONTRACT CLAUSES
This contract incorporates the following clauses by reference, (unless otherwise noted), with the same force and
effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.
a.
b.
c.
d.
THO
Faeposg-r
FAR Clause 52.212-3, Offeror Representations and Certifications-Commercial Items
FAR Clause 52.212-4 Contract Terms and Conditions - Commercial Items (Oct 2018)
FAR Clause 52.203-13, Contractor Code of Business Ethics and Conduct (October 2015)
FAR Clause 52.204-2, Security Requirements (August 1996).
1. Alternate | (April 1984) is not applicable to this contract.
2. Alternate II (April 1984) is not applicable to this contract.
FAR Clause 52.204-9, Personal Identity Verification of Contractor Personnel (January 2011).
FAR Clause 52.204-13, System for Award Management Maintenance
FAR Clause 52.204-18 Commercial and Government Entity Code Maintenance (July 2016)
FAR Clause 52.204-23 Prohibition on Contracting for Hardware, Software, and Services Developed or
Provided by Kaspersky Lab and Other Covered Entities
FAR Clause 52.209-10, Prohibition on Contracting With Inverted Domestic Corporations(November
2015).
FAR Clause 52.222-4, Contract Work Hours and Safety Standards - Overtime Compensation -General
(May 2014).
FAR Clause 52.222-29, Notification of Visa Denial (April 2015).
FAR Clause 52.223-15, Energy Efficiency in Energy-Consuming Products (December 2007).
. FAR Clause 52.224-1, Privacy Act Notification (April 1984).
FAR Clause 52.224-2, Privacy Act (April 1984).
FAR Clause 52.227-11 Patent Rights-Ownership by the Contractor
FAR Clause 52.227-14, Rights in Data - General (May 2014).
FAR Clause 52.227-14, Rights in Data - General (May 2014) Alternate II (Dec 2007).
FAR Clause 52.232-40, Providing Accelerated Payments to Small Business Subcontractors
ARTICLE 1.2, ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT
FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES
Additional clauses other than those listed below which are based on the type of contract/Contractor
shall be determined during negotiations. This contract incorporates the following clauses in full text.
1. FAR 52.216-23 - EXECUTION AND COMMENCMENT OF WORK (APR 1984)
The Contractor shall indicate acceptance of this letter contract by signing One Copy of this Letter
Contract and returning to the Contracting Officer not later than July 29, 2020 at 10:00 p.m. Eastern.
Upon acceptance by both parties, the Contractor shall proceed with performance of the work,
including purchase of necessary materials.
Contract number 75N92020C00014 Page 12
2. FAR 52.216-24 - LIMITATION OF GOVERNMENT LIABILITY (APR 1984)
(a) In performing this Letter Contract, the Contractor is not authorized to make expenditures orincur
obligations exceeding $5,991,604 dollars.
(b) The maximum amount for which the Government shall be liable if this Letter Contract is
terminated is $5,991,604 dollars.
3. FAR 52.216-25 - CONTRACT DEFINITIZATION (OCT 2010)
(a) A Firm Fixed Price (FFP) definitive contract is contemplated. The Contractor agrees to begin promptly
negotiating with the Contracting Officer the terms of a definitive contract that will include (1) all clauses
required by the Federal Acquisition Regulation (FAR) on the date of execution of the letter contract, (2) all
clauses required by law on the date of execution of the definitive contract, and (3) any other mutually
agreeable clauses, terms, and conditions. The Contractor agrees to submit a Firm Fixed Price proposal,
including data other than certified cost or pricing data, and certified cost or pricing data, in accordance with
FAR 15.408, Table 15-2, supporting its proposal.
The schedule for definitizing this contract is as follows:
Definitization Schedule Date
Letter Contract Post Award Kick Off meeting 07/31/2020
Contractor Technical and Revised Price 08/14/2020
Proposal Submittal including other than
certified cost or pricing data
Project Officer’s Technical 08/20/2020
Questionnaire/Technical Evaluation &Review
Negotiations Start 08/21/2020
Definitization of Letter Contract 09/10/2020
(b) If agreement on a definitive contract to supersede this letter contract is not reached by the target
date in paragraph (b) of this section, or within any extension of it granted by the Contracting
Officer, the Contracting Officer may, with the approval of the head of the contracting activity,
determine a reasonable price or fee in accordance with subpart 15.4 and part 31 of the FAR,
subject to Contractor appeal as provided in the Disputes clause. In any event, the Contractor shall
proceed with completion of this Letter Contract, subject only to the Limitation of Government
Liability clause.
(1) After the Contracting Officer’s determination of price or fee, this Letter Contract shallbe
governed by-
(i) All clauses required by the FAR on the date of execution of this Letter Contract for
either fixed-price or cost-reimbursement contracts, as determined by the Contracting
Officer under this paragraph (c);
(ii) All clauses required by law as of the date of the Contracting Officer’s determination;
and
(iii) Any other clauses, terms, and conditions mutually agreed upon.
Contract number 75N92020C00014 Page 13
(2) To the extent consistent with paragraph (c)(1) of this section, all clauses, terms, and
conditions included in this Letter Contract shall continue in effect, except those that by
their nature apply only to a Letter Contract.
4. FAR Clause 52.204-21, Basic Safeguarding of Covered Contractor Information Systems (Jun 2016)
(a) Definitions. As used in this clause—
Covered contractor information system means an information system that is owned or
operated by a contractor that processes, stores, or transmits Federal contract
information.
Federal contract information means information, not intended for public release, that is
provided by or generated for the Government under a contract to develop or deliver a
product or service to the Government, but not including information provided by the
Government to the public (such as on public websites) or simple transactional
information, such as necessary to process payments.
Information means any communication or representation of knowledge such as facts,
data, or opinions, in any medium or form, including textual, numerical, graphic,
cartographic, narrative, or audiovisual (Committee on National Security Systems
Instruction (CNSSI) 4009).
Information system means a discrete set of information resources organized for the
collection, processing, maintenance, use, sharing, dissemination, or disposition of
information (44 U.S.C. 3502).
Safeguarding means measures or controls that are prescribed to protect information
systems.
(b) Safeguarding requirements and procedures.
(1) The Contractor shall apply the following basic safeguarding requirements and
procedures to protect covered contractor information systems. Requirements and
procedures for basic safeguarding of covered contractor information systems shall
include, at a minimum, the following security controls:
(i) Limit information system access to authorized users, processes acting on behalf of
authorized users, or devices (including other information systems).
(ii) Limit information system access to the types of transactions and functions that
authorized users are permitted to execute.
(iii) Verify and control/limit connections to and use of external information systems.
(iv) Control information posted or processed on publicly accessible information
systems.
Contract number 75N92020C00014 Page 14
(v) Identify information system users, processes acting on behalf of users, or devices.
(vi) Authenticate (or verify) the identities of those users, processes, or devices, as a
prerequisite to allowing access to organizational information systems.
(vii) Sanitize or destroy information system media containing Federal Contract
Information before disposal or release for reuse.
(viii) Limit physical access to organizational information systems, equipment, and the
respective operating environments to authorized individuals.
ix) Escort visitors and monitor visitor activity; maintain audit logs of physical access;
and control and manage physical access devices.
x) Monitor, control, and protect organizational communications (i.e., information
transmitted or received by organizational information systems) at the external
boundaries and key internal boundaries of the information systems.
xi) Implement subnetworks for publicly accessible system components that are
physically or logically separated from internal networks.
xii) Identify, report, and correct information and information system flaws in a timely
manner.
xiii) Provide protection from malicious code at appropriate locations within
organizational information systems.
xiv) Update malicious code protection mechanisms when new releases are available.
xv) Perform periodic scans of the information system and real-time scans of files from
external sources as files are downloaded, opened, or executed.
(2) Other requirements. This clause does not relieve the Contractor of any other specific
safeguarding requirements specified by Federal agencies and departments relating to
covered contractor information systems generally or other Federal safeguarding
requirements for controlled unclassified information (CUI) as established by Executive
Order 13556.
(c) Subcontracts. The Contractor shall include the substance of this clause, including this
paragraph (c), in subcontracts under this contract (including subcontracts for the
acquisition of commercial items, other than commercially available off-the-shelf items), in
which the subcontractor may have Federal contract information residing in or transiting
through its information system.
(End of clause)
5. FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-
Commercial Items (Jul 2020)
(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses,
Contract number 75N92020C00014 Page 15
which are incorporated in this contract by reference, to implement provisions of law or
Executive orders applicable to acquisitions of commercial items:
(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or
Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further
Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in
subsequent appropriations acts (and as extended in continuing resolutions)).
(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or
Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L.
115-91).
(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video
Surveillance Services or Equipment. (Aug 2019) (Section 889(a)(1)(A) of Pub. L. 115-
232).
(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov
2015).
(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).
(6) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and
108-78 ( 19 U.S.C. 3805 note)).
(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting
Officer has indicated as being incorporated in this contract by reference to implement
provisions of law or Executive orders applicable to acquisitions of commercial items:
[Contracting Officer check as appropriate.)
Selections will be made by the Contracting Officer during definitization.
___ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (JUNE 2020),
with Alternate | (Oct 1995) ( 41U.S.C.4704 and 10 U.S.C. 2402).
___ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509)).
___ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment
Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the
American Recovery and Reinvestment Act of 2009.)
__ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN
2020) (Pub. L. 109-282) ( 31 U.S.C. 6101 note).
___ (5) [Reserved].
___ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section
743 of Div. C).
___ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery
Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).
___ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors
Debarred, Suspended, or Proposed for Debarment. (JUN 2020) (31 U.S.C. 6101 note).
___ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (OcT
2018) (41 U.S.C. 2313).
___ (10) [Reserved].
Contract number 75N92020C00014 Page 16
___ (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (MAR
2020) (15 U.S.C. 657a).
__ (ii) Alternate | (MAR 2020) of 52.219-3.
___ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business
Concerns (Mar 2020) (if the offeror elects to waive the preference, it shall so indicate in its
offer) (15 U.S.C. 657a).
__ (ii) Alternate | (Mar 2020) of 52.219-4.
___ (13) [Reserved]
___ (14) (i) 52.219-6, Notice of Total Small Business Set-Aside (Mar 2020) of 52.219-
6 (15 U.S.C. 644).
___(ii) Alternate | (MAR 2020) of 52.219-6 .
___ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (Mar 2020) (15 U.S.C. 644).
__ (ii) Alternate | (MAR 2020) of 52.219-7.
___ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).
___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Jun 2020) (15 U.S.C. 637(d)(4)).
___ (ii) Alternate | (Nov 2016) of 52.219-9.
__ (iii) Alternate II (Nov 2016) of 52.219-9.
___(iv)Alternate III (Jun 2020) of 52.219-9.
__ (v)AlterNaTE IV (JUN 2020) OF 52.219-9
___ (18) (i) 52.219-13, Notice of Set-Aside of Orders (Mar 2020) (15 U.S.C. 644(r)).
___ (ii) Alternate | (Mar 2020) of 52.219-13.
___ (19) 52.219-14, Limitations on Subcontracting (Mar 2020) (15 U.S.C. 637(a)(14)).
___ (20) 52.219-16, Liquidated Damages-Subcontracting Plan (Jan
1999) (15 U.S.C. 637(d)(4)(F)(i)).
___ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Mar
2020) (15 U.S.C. 657f).
___ (22) (i) 52.219-28, Post Award Small Business Program Rerepresentation (May
2020) (15 U.S.C. 632(a)(2)).
__ (ii) Alternate | (MAR 2020) of 52.219-28.
___ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged
Women-Owned Small Business Concerns (Mar 2020) (15 U.S.C. 637(m)).
___ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small
Business Concerns Eligible Under the Women-Owned Small Business Program (Mar2020)
(15 U.S.C. 637(m)).
___ (25) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020)(15 U.S.C.
644(r)).
___ (26) 52.219-33, Nonmanufacturer Rule (Mar 2020) (15U.S.C. 637(a)(17)).
__ (27) 52.222-3, Convict Labor (Jun 2003) (£.0.11755).
___ (28) 52.222-19, Child Labor- Cooperation with Authorities and Remedies (Jan2020)
(E.0.13126)
___ (29) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).
__ (30) (i) 52.222-26, Equal Opportunity (Sep 2016) (E.0.11246).
__ (ii) Alternate | (Fe8 1999) of 52.222-26.
__ (31) (i) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).
___ (ii) Alternate | (JuL 2014) of 52.222-35.
___ (32) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).
__ (ii) Alternate | (JUL 2014) of 52.222-36.
___ (33) 52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).
Contract number 75N92020C00014 Page 17
___ (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec
2010) (E.0. 13496).
___ (35) (i) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.0.
13627).
___ (ii) Alternate | (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).
___ (36) 52.222-54, Employment Eligibility Verification (Oct 2015). (Executive Order 12989). (Not
applicable to the acquisition of commercially available off-the-shelf items or certain other
types of commercial items as prescribed in 22.1803.)
___ (37) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA—Designated
Items (May 2008) ( 42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of
commercially available off-the-shelf items.)
___ (ii) Alternate | (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the
acquisition of commercially available off-the-shelf items.)
___ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential
Hydrofluorocarbons (Jun 2016) (E.0. 13693).
___ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air
Conditioners (Jun 2016) (E.0. 13693).
__ (40) (i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.0.s
13423 and 13514).
___ (ii) Alternate | (Oct 2015) of 52.223-13.
__ (41) (i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.0.s 13423 and
13514).
__ (ii) Alternate | (Jun2014) of 52.223-14.
___ (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (May
2020) (42 U.S.C. 8259b).
___ (43) (i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OcT
2015) (E.0.s 13423 and 13514).
___ (ii) Alternate | (JUN 2014) of 52.223-16.
__ (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun
2020) (E.0. 13513).
___ (45) 52.223-20, Aerosols (Jun 2016) (E.0. 13693).
___ (46) 52.223-21, Foams (Jun2016) (E.0. 13693).
___ (47) (i) 52.224-3 Privacy Training (JAN 2017) (5 U.S.C. 552 a).
__ (ii) Alternate | (JAN 2017) of 52.224-3.
__ (48) 52.225-1, Buy American-Supplies (May 2014) (41 U.S.C. chapter 83).
__ (49) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (May
2014) (41 U.S.C.chapter83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19
U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-
283, 110-138, 112-41, 112-42, and 112-43.
__ (ii) Alternate | (May 2014) of 52.225-3.
__ (iii) Alternate Il (May 2014) of 52.225-3.
__ (iv) Alternate III (May 2014) of 52.225-3.
___ (50) 52.225-5, Trade Agreements (Oct 2019) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).
___ (51) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.0.’s, proclamations,
and statutes administered by the Office of Foreign Assets Control of the Department of the
Treasury).
___ (52) 52.225-26, Contractors Performing Private Security Functions Outside the United States
(Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal
Contract number 75N92020C00014 Page 18
Year 2008; 10 U.S.C. 2302Note).
___ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov2007) (42 U.S.C. 5150).
___ (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov2007)
(42 U.S.C. 5150).
___ (55) 52.229-12, Tax on Certain Foreign Procurements (JUN 2020).
___ (56) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb
2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).
__ (57) 52.232-30, Installment Payments for Commercial Items (Jan2017)
(41 U.S.C. 4505, 10 U.S.C. 2307(f)).
___ (58) 52.232-33, Payment by Electronic Funds Transfer-System for Award
Management (Oct2018) (31 U.S.C. 3332).
__ (59) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award
Management (Jul 2013) (31 U.S.C. 3332).
___ (60) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).
___ (61) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).
___ (62) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(13)).
__ (63) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Fe
2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).
__ (ii) Alternate | (Apr 2003) of 52.247-64.
__ (iii) Alternate I! (Fe8 2006) of 52.247-64.
(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial
services, that the Contracting Officer has indicated as being incorporated in this contract by
reference to implement provisions of law or Executive orders applicable to acquisitions of
commercial items:
[Contracting Officer check as appropriate.)
___ (1) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter67).
___ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May
2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).
___ (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price
Adjustment (Multiple Year and Option Contracts) (Aug
2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).
__ (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price
Adjustment (May 2014) ( 29U.S.C.206 and 41 U.S.C. chapter 67).
___ (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to
Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May
2014) (41 U.S.C. chapter 67).
___ (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to
Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67).
___ (7) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).
___ (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.0. 13706).
___ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020)
(42 U.S.C. 1792).
(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of
this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the
simplified acquisition threshold, as defined in FAR 2.101, on the date of award of this contract,
and does not contain the clause at 52.215-2, Audit and Records-Negotiation.
(1) The Comptroller General of the United States, or an authorized representative of the
Contract number 75N92020C00014 Page 19
Comptroller General, shall have access to and right to examine any of the Contractor’s
directly pertinent records involving transactions related to this contract.
(2) The Contractor shall make available at its offices at all reasonable times the records,
materials, and other evidence for examination, audit, or reproduction, until 3 years after
final payment under this contract or for any shorter period specified in FAR subpart 4.7,
Contractor Records Retention, of the other clauses of this contract. If this contract is
completely or partially terminated, the records relating to the work terminated shall be
made available for 3 years after any resulting final termination settlement. Records relating
to appeals under the disputes clause or to litigation or the settlement of claims arising under
or relating to this contract shall be made available until such appeals, litigation, or claims are
finally resolved.
(3) As used in this clause, records include books, documents, accounting procedures and
practices, and other data, regardless of type and regardless of form. This does not require
the Contractor to create or maintain any record that the Contractor does not maintain in
the ordinary course of business or pursuant to a provision of law.
(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this
clause, the Contractor is not required to flow down any FAR clause, other than those in this
paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the
extent of the flow down shall be as required by the clause-
(i) 52.203-13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509).
(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or
Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further
Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in
subsequent appropriations acts (and as extended in continuing resolutions)).
(iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or
Provided by Kaspersky Lab and Other Covered Entities (JUL 2018) (Section 1634 of Pub. L.
115-91).
(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video
Surveillance Services or Equipment. (AUG 2019) (Section 889(a)(1)(A) of Pub. L. 115-232).
(v) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)), in
all subcontracts that offer further subcontracting opportunities. If the subcontract (except
subcontracts to small business concerns) exceeds the applicable threshold specified in
FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219-
8 in lower tier subcontracts that offer subcontracting opportunities.
(vi) 52.222-21, Prohibition of Segregated Facilities (APR 2015).
(vii) 52.222-26, Equal Opportunity (Sep 2015) (E.0.11246).
(viii) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).
(ix) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).
(x) 52.222-37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).
(xi) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC
2010) (E.0. 13496). Flow down required in accordance with paragraph (f) of FAR
clause 52.222-40.
(xii) 52.222-41, Service Contract Labor Standards (Aug2018) (41 U.S.C. chapter 67).
(xiii) (A) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.O
13627).
Contract number 75N92020C00014 Page 20
(B) Alternate | (Mar2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).
(xiv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to
Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements
(May2014) (41 U.S.C. chapter 67).
(xv) 52.222-53, Exemption from Application of the Service Contract Labor Standards to
Contracts for Certain Services-Requirements (MAY2014) (41 U.S.C. chapter 67).
(xvi) 52.222-54, Employment Eligibility Verification (OcT 2015) (E.0. 12989).
(xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).
(xviii) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.0. 13706).
(xix) (A) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).
(B) Alternate | (Jan 2017) of 52.224-3.
(xx) 52.225-26, Contractors Performing Private Security Functions Outside the United
States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for
Fiscal Year 2008; 10 U.S.C. 2302 Note).
(xxi) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun
2020) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR
clause 52.226-6.
(xxii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb
2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance
with paragraph (d) of FAR clause 52.247-64,
(2) While not required, the Contractor may include in its subcontracts for commercial items a
minimal number of additional clauses necessary to satisfy its contractual obligations.
(End of clause)
6. FAR 52.217-7 Option for Increased Quantity — Separately Priced Line Item
The Government may require the delivery of the numbered line item, identified in the Schedule as an
option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise
the option by written notice to the Contractor within the period of performance of the contract. Delivery
of added items shall continue at the same rate that like items are called for under the contract, unless the
parties otherwise agree.
(End of Clause)
PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS
SECTION J LIST OF ATTACHMENTS
1. Statement of Objectives
a. Appendix 1: Schedule of Deliverables/Milestones
Contract number 75N92020C00014 Page 21
Attachment 1 — Statement of Objectives
Statement of Objectives
Program Title: Rapid Acceleration of Diagnostics (RADx) — Tech
Project Title: Easy to Use, Low-Cost Molecular-Based SARS-CoV-2 Test, Highly Scalable (Mesa Biotech, Inc.)
Agency: National Institute of Biomedical Imaging and Bioengineering (NIBIB) / National Institutes of Health
(NIH)
1. Background
The National Institute of Biomedical Imaging and Bioengineering (NIBIB) has an open solicitation for
proposals to provide up to $500 million across multiple projects to rapidly produce innovative SARS-CoV-2
diagnostic tests that will assist the public’s safe return to normal activities. Rapid Acceleration of Diagnostics
(RADx), is a fast-track technology development program that leverages the National Institutes of Health
(NIH) Point-of-Care Technology Research Network (POCTRN). RADx will support novel solutions that build
the U.S. capacity for SARS-CoV-2 testing up to 100-fold above what is achievable with standard approaches.
RADx is structured to deliver innovative testing strategies to the public as soon as late summer 2020 and is
an accelerated and comprehensive multi-pronged effort by NIH to make SARS-CoV-2 testing readily available
to every American.
2. Purpose and Objectives
NIBIB is providing substantial support to accelerate the development, validation, and commercialization of
innovative point-of-care and home-based tests, as well as improvements to clinical laboratory tests, that
can directly detect SARS-CoV-2, the virus that causes COVID-19. NIBIB will support the full range of product
development including commercialization and product distribution. The ultimate goal of the RADx program
— across multiple projects/contracts — is to make millions of tests per week available to the American public,
particularly those most vulnerable to and/or disproportionately impacted by COVID-19, in the late summer
of 2020, and having even more tests available in time for the 2020-2021 flu season.
To meet the accelerated timelines, RADx has assembled a national network of expert technical, clinical,
manufacturing, and regulatory advisors who will provide individualized assistance for project development
and commercialization. Funding for projects selected for this program will be dependent on successfully
meeting aggressive project milestones. NIBIB will provide financial and in-kind support to accelerate the
entire product life-cycle, from design to market, for projects that meet milestones successfully. To ensure
that innovations are available to the public as quickly as possible, NIH will leverage established partnerships
with federal agencies, such as FDA, CDC, CMS, ASPR/BARDA, the Department of Defense, as well as
commercial and private entities to propel technologies developed by RADx into widespread use.
The RADx program will consider innovations at all stages of readiness to circumvent current limitations to
SARS-CoV-2 testing capacity, including:
— Early stage: transformative innovations based on novel testing strategies that have potential for
major scale up
— Mid stage: technologies using novel testing strategies that have demonstrated capability but need
further validation, regulatory approval, and scale up
= Advanced stage (RADx ATP): modification and optimization of existing SARS-CoV-2 testing
approaches, including clinical laboratory tests, that can dramatically increase testing capacity. Note:
This arm of the RADx program is addressed under a separate Acquisition Plan.
Page 1 of 3
Attachment 1 — Statement of Objectives
Design features might include technical innovations that:
3.
— Improve analytical performance, e.g., sensitivity, specificity, dynamic range, limit of detection,
reliability, accuracy, speed (time to test result) and throughput
— Enhance operational performance through, e.g., development of a patient- and user-friendly design,
use of alternative sampling strategies (e.g., saliva, exhaled breath), integration with mobile-devices,
designs for home-based use or strategies to overcome bottlenecks with current testing approaches
— Improve access and reduce the cost of testing.
Scope
RADx-Tech is a two phase program. All applications undergo an intensive week-long risk assessment by a
panel of expert technical, clinical, manufacturing, and regulatory advisors. If the proposed technology meets
viability metrics, projects may be selected to enter phase one.
Phase one, performed under a separate funding mechanism, consists of an accelerated research and
development program in which the awardee receives both financial support and in-kind services through
RADx grant funding. This outcome of this work is a fully instantiated technology ready for clinical validation,
regulatory authorization, production and commercialization.
Phase two, or Work Package 2, of the program, executed under this contract, includes completing clinical
validation and implementation of production processes in order to deliver a viable product in a scaled up
capacity to the U.S. public.
Performance Objectives (Required Results)
Contract recipients have completed major research and development efforts and are focused in phase
two on completion of required clinical validation, preparation of regulatory submissions, scale-up of
production capabilities, and preparation for full commercialization of their product — a testing
technology. Every contract will encompass similar expectations and milestones concerned with:
1. meeting regulatory requirements, resulting in regulatory authorization for sale and use of the test;
2. instantiation of agreed-upon production capacity;
3. meeting agreed-upon production goals; and
4. implementation of an agreed-upon commercial strategy to bring the test to market in a timeframe
that will impact the COVID-19 pandemic as soon as possible.
Contract funding in phase two is structured in order to reduce risk to the Government, and is dependent
on achievement of specific milestones in the Schedule of Deliverables, according to the Payment
Schedule.
The contractor must use a SARS-Cov-2 test with FDA EUA, indicating a combination of sensitivity,
specificity, and usability appropriate to the intended use according to FDA and/or CDC guidance, as
applicable.
The contractor must make the product available for independent regulatory/validation assessment. The
independent assessor will be selected by the Government.
Page 2 of 3
Attachment 1 — Statement of Objectives
5. Contract Type
The contract type is Firm Fixed Price.
6. Place of Performance
The place of performance will be at the contractor’s site.
7. Period of Performance
The period of performance is July 30, 2020 through July 29, 2021.
8. Option for Increased Services
Options for increased quantity/services will be contemplated for each contract awarded under RADx Tech.
Options include purchase of approximately 300 docks and 15,000 cassettes per month for four months to
support an Operation Warp Speed vaccine trial.
9. Reporting Requirements/Deliverables
The following reporting requirements will required:
Item No. Reporting Requirements ie Date
1 Bi-weekly Production Status Report — to include Bi-weekly until the end of
current plant production capacity and output ona February 2021
per-week basis, and a description of any
issues/problems encountered with plans for
solution/mitigation (e.g., delays in meeting
deliverables, supply chain issues, design/validation
issues, etc.)
2 Monthly Production Report - Current plant Monthly
production capacity and break down capacity and
output on a per-line/per week basis
See Appendix 1 for List of Deliverables/Milestones
10. Other Requirements
A. The contractor must meet regularly (at least weekly) with NIH officials to update on progress toward
deliverables; anticipated and ongoing issues and problems; and timelines for deliverable completion.
When guided by NIH officials, the contractor must be willing to collaborate and cooperate with external
organizations as needed to meet the contract goals in a manner which will not infringe contractor
commercial or intellectual property rights.
11. Appendices
1. List of Deliverables/Milestones
Page 3 of 3
‘Appendix 1: List of Deliverables/Milestones
No | Objective Defined
Milestone Defined
Deliverable
Success Criteria/Objective Evidence
Deliverable Due Date| Fixed Price
(oy
10
u
2
rey
pay
Total
[OPTIONAL WORK: (to be negotiated)
Description
foray
Unit Price
Quantity
Estimated Not-To-Exceed Total
Day
‘SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS. f, RENUSINON MEER Paae OF
OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30 5763920 1 20
2 CONTRACT NO, [3 AWAROY Js. ORDER NUMBER 5. SOLICITATION NUMBER Is. SOLICITATION
75N92020C00009 EFFECTIVE DATE Issue OATE
7. FOR SOLICITATION fa. NAME jp TELEPHONE NUMBER (No colect call) JB. OFFER DUE DATELOCAL TINE
INFORMATION CALL: LINDA SMITH +1 301 827-7741
9, ISSUED BY cove [NHLBI 10. THISACQUISITIONIS UNRESTRICTED OR SET ASIDE: % FOR:
, . WOMEN-OWNED SMALL BUSINESS
National Institutes of Health SMALL BURINEDS. (WOSB) ELIGIBLE UNDER THE WOMEN-OWNED
National Heart, Lung, and Blood HUBZONE SMALL SMAI RIISINFSS PROGRAM watcs:334516
Institute BUSINESS eDWwoss
SSERVICE-DISABLED
Bethesda, MD 20892-7511 sean BA) size stanparo; 1,000
‘SMALL BUSINESS
Wi, DELIVERY FOR FOB DESTINA- [12 DISCOUNT TERMS 3b, RATING
TION UNLESS BLOCK IS 13a, THIS CONTRACT ISA
MARKED RATED ORDER UNDER
Ta. METHOD OF SOLICITATION
X) SEE SCHEDULE DPAS (15 CFR 700) eas Hat ne
75. DELIVER TO Coe TDP, BTHOFF [6 ADMINISTERED BY ‘CODE NIBIB
Two Democracy Plaza, Bethesda Off C
2 Democracy Plaza
6707 Democracy Blvd
Bethesda MD 20817
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering
Bethesda, MD 20892-7511
17a, CONTRACTOR!
OFFEROR
‘CODE FACILITY
‘CODE
FLUIDIGM CORPORATION:1157584
2 TOWER PLACE SUITE 2000
SOUTH SAN FRANCISCO CA 940801826
[18a. PAYMENT WILL BE MADE BY
CODE NHLBI INV-BR
[Approved By, NHLBI Branch A Invoice
Paid By: NIH Commercial Accounts Br
2115 East Jefferson St, MSC 8500
Room 4B-432
Bethesda, MD 20892-8500
‘TELEPHONE NO,
7b, CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER [18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW
1S CHECKED ‘SEE ADDENDUM
19, 20. 2 22. 23. 24,
ITEM NO, ‘SCHEDULE OF SUPPLIES/SERVICES QUANTITY |UNIT UNIT PRICE AMOUNT
INIBID: 75N92020C00009 Rapid Acceleration of
Diagnostics ( RADx) Program: Tech Project # 6114
Fluidigm - Advanta Dx SARS-CoV-2 RT-PCR Assay for
Saliva
Period of Performance: 07/30/2020 to 07/29/
Stage 1 - Test Verification
lobligated Amount:
Delivery To: Bldg.31/RM 1C31
continued
(Use Reverse and/or Attach Additional Sheets as Necessary)
25. ACCOUNTING AND APPROPRIATION DATA
2021
TOTAL AWARD AMOUNT (For Govt. Use Only)
$12,151,000.00
27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.2123 AND 52.212-5 ARE ATTACHED. ADDENDA ARE |_ ARE NOT ATTACHED.
X 27b, CONTRACTIPURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA X ARE ARE NOT ATTACHED.
'28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN 1 29. AWARD OF CONTRACT: OFFER
COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER
ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL
SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.
DATED YOUR OFFER ON SOLICITATION (BLOCK 5),
INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH
HEREIN. IS ACCEPTED AS TO ITEMS:
‘30a, SIGNATURE OF OFFERORIGONTRACTOR
by)
Bia, UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)
Digitally signed by Roxane S. Burkett -S.
Roxane S. Burkett -S piste 2020.07 30073045 04°00
VBS OF E SIGNED
712912020
S. Christopher Linthwaite, President and CEO
[31b. NAME OF CONTRACTING OFFICER (Type or print) [31c. DATE SIGNED
ROXANE S. BURKETT
AUTHORIZED FOR LOCAL REPRODUCTION
PREVIOUS EDITION IS NOT USABLE
‘STANDARD FORM 1449 (REV. 2/2012)
Prescribed by GSA - FAR (48 CFR) 53.212
19, 20. 21 2 23. 24
ITEM No, ‘SCHEDULE OF SUPPLIESISERVICES ‘QuantiTy | UNIT UNIT PRICE AMOUNT
Product/Service Code: Q301
Product/Service Description: MEDICAL- LABORATORY
TESTING
Delivery: 08/08/2020
2 Stage 1A - Design Review pe |
Delivery To: Bldg.31/RM 1C31
Product/Service Code: Q301
Product/Service Description: MEDICAL- LABORATORY
TESTING
Delivery: 09/12/2020
32a, QUANTITY IN COLUMN 21 HAS BEEN
RECEIVED INSPECTED ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:
32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE
32b, SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32c. DATE
32e, MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE 32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE
32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE
37. CHECK NUMBER
33, SHIP NUMBER, [35. AMOUNT VERIFIED 36. PAYMENT
CORRECT FOR
COMPLETE
PARTIAL
PARTIAL
38, SIR ACCOUNT NUMBER 40. PAID BY
139. SIR VOUCHER NUMBER
41a. | CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT. 42a. RECEIVED BY (Print)
41b, SIGNATURE AND TITLE OF CERTIFYING OFFICER
‘4c. DATE
42b. RECEIVED AT (Location)
42d, TOTAL CONTAINERS
‘STANDARD FORM 1449 (REV. 2/2012) BACK
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
ARTICLE B.1. BRIEF DESCRIPTION OF SERVICES
This Letter Contract formsa preliminary understanding between Fluidigm Corporation and the National
Institutes of Health (NIH) andis issued as a result of the Rapid Acceleration of Diagnostics Advanced Technology
Platforms (RADx-ATP) to increase the testing capacity of high throughput labs by scaling up late stage testing
platforms for detecting SARS-CoV-2, the virus that causes COVID-19. Issuance of this Letter Contract authorizes
the Contractor to immediately begin the activities necessary to perform the requirements as identified in the
Statement of Objectives covering the full range of activities needed to increase capacity and optimize
throughput necessary to distribute a viable product to the public.
The scope of work executed under this contract, includes completing the validation, approval, and production
processes in order to deliver a viable productin a scaled up capacity to the U.S. public. Fluidigm technology to
support this effort will be to scale up the Integrated Fluidic Circuit (IFC) and completion of the multiplex assay
development system for rapid acceleration of testing.
This Letter Contract has been issued based on the application and preliminary work file submitted by the
contractor and subsequent documentation submitted during the Point of Care Teachnology Research Network
(POCTRN) application review process. The Contractor's inability to meet the requirements as defined within this
Letter Contract and proposed within the POCTRN application process may result in the termination of the Letter
Contract in accordance with the termination clauses contained herein.
ARTICLE B.2. PRICES
a. The total Firm Fixed Price (FFP) amount for this Letter Contract is $12,151,000.
Payment Schedule
[See complete breakdown in Deliverable Schedule]
| Milestone
Stage 1 — Test Verification
Stage 1A — Design Review |_|
| Total 12,151,000
ARTICLE B.3. ADVANCE UNDERSTANDINGS
a. The parties acknowledge and agree that the situation around COVID-19is highly dynamic, evolving
rapidly, and subject to significant uncertainty. The Letter Contract is being executed onan expedited
timeline to meet an urgent and compelling government need without the benefit of prior negotiation.
Thus, the parties will negotiate in good faith to ensure that the definitized contract reflects an
appropriate allocation of risk and responsibility and that it is consistent with the application and
preliminary work file submitted by the contractor and subsequent documentation submitted during the
application review process and the discussions between the parties that have taken place between date
of application submission through Letter Contract issuance. Until the Performance Work Statement
(PWS) is finalized the Statement of Objective (SOO) willgovern.
b. The parties anticipate that the definitive contract resulting from this Letter Contract will include a
Contract number: 75N92020C00009 Page 1
negotiated firm fixed price not to exceed $36,834,000. The amount of funding provided for this Letter
Contract is stated in Article B.2 avove, the contractor shall not incur costs in excess of this amount.
c. Commercial Item Status: The services provided by the Contractor under the Letter Contract and any
definitized contract constitute commercial item services, and the terms of any definitized contract will
reflect that understanding.
d. Performance Work Statement: The parties will negotiate the Performance Work Statementinthe
process of contract definitization to fairly reflect the application and preliminary work file submitted
by the contractor and subsequent documentation submitted during the application review process and
the discussions between the parties that have taken place between application submission through
letter contract issuance.
e. HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to
include rating this order in accordance with 45 CFR Part 101, Subpart A—Health Resources Priorities
and Allocations System.
f. The parties agree prior to negotiate further the terms of milestone payments to include in the
definitized contract. In the negotiation, the parties will consider terms addressing liquidation, time and
criteria of milestone payments.
g. Successful performance underthis contract requires the Contractor obtain and maintain an Emergency
Use Authorization (EUA) from the Food and Drug Administration (FDA); the Contractor shall copy us on
all FDA correspondence related to the project, including email communications to and from the FDA.
The FDA EUA services provided under this Letter Contract constitute a commercial service to detect
SARS-CoV-2.
h. Fair Pricing: The Rapid Acceleration of Diagnostics (RADx) application review process determined the cost
per test is competitive with the current market price. The Contractor must comply with applicable
federallaw to ensure that prices to consumersare offered atfair market rate and ata rate
consistent with the objective to increase and improve testing in the United States andits territories.
i. In accordance with the goals of the RADx program, the tests manufactured under this contract are to
be sold within the U.S. and its territories; provided, however, that, to the extent there is insufficient
demand within the U.S. and its territories for the tests produced up to the additional manufacturing
capacity funded by NiHand then available (as described in the Schedule of Deliverables), contractor will
be permitted to sell such tests outside the U.S. and its territories. The factors, process and mechanism
to determine whether contractor has insufficient demand for the tests up to the then-available capacity
will be determined in the definitive contract.
j. Sharing Data and Reports: The Contractor will be required to provide data and reports (e.g.,
manufacturing, supply chain, production rates), which NIH will use to evaluate completion or
achievement of milestones, progress toward deliverables, and compliance with the requirements of
this Letter Contract. NIH may use the data to coordinate with other U.S. Government Agencies to
accelerate development and deployment of innovative COVID-19 diagnostic tests, and ensure effective
stewardship of federalfunds. Sharing data within the federal government enables NIHto discuss the
project’s challenges and progress with federal agencies offering scientific, manufacturing, and logistics
expertise. To ensure that innovations are available to the public as quickly as possible, NIH will leverage
Contract number: 75N92020C00009 Page2
established partnerships with federal agencies, such as FDA, CDC, CMS, ASPR/BARDA, and the
Department of Defense, and partnerships with State agencies to propel technologies developed by RADx
into widespread use.
k. Contractor Facilities: The contractor shall certify that they will maintain their Facility and Equipmentin
satisfactory operating condition, as required to enable the contractor to perform the deliverables and
achieve the milestones in accordance with the Statement of Objectives and all other applicable laws,
regulations, rules or orders. Routine repairs, preventive maintenance, and service contracts for the
Facility and Equipment shall be arranged by contractor at no additional cost to the Government.
|. FAR 52.212-4 (I), the Government reserves the right to terminate this contract, or any part hereof, for its
sole convenience. In the event of such termination, the Contractor shall immediately stop all work
hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work.
Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price
reflecting the percentage of the work performed prior to the notice of termination, plus reasonable
charges the Contractor can demonstrate to the satisfaction of the Government using its standard record
keeping system, have resulted from the termination. The Contractor shall not be required to comply
with the cost accounting standards or contract cost principles for this purpose. This paragraph does not
give the Government any right to audit the Contractor's records. The Contractor shall not be paid for
any work performed or costs incurred which reasonably could have been avoided.
m. Letter Contract Termination: In accordance with FAR 52.212-4(m), the Government may terminate this
contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor
fails to comply with any contract terms and conditions, or fails to provide the Government, upon
request, with adequate assurances of future performance. In the event of termination for cause, the
Government shall not be liable to the Contractor for any amount for supplies or services not accepted,
and the Contractor shall be liable to the Government for any and all rights and remedies provided by
law. If it is determined that the Government improperly terminated this contract for default, such
termination shall be deemed termination for convenience.
n. Security and Privacy of Protected Health Information (PHI) processed under this contract: The
Contractor , shall meet the definition of either a Covered Entity or Business Associate under the Health
Insurance Portability and Accountability Act of 1996 (HIPAA). The contractor shall therefore comply
with the HIPAA regulatory standards set forth in the Code of Federal Regulations (CFR) 45 C.F.R. Part
160, Part 162, and Part 164. To the extent that the Contractor engages subcontractors or other Business
Associates to provide services under this Contract, and such Subcontractors or Business Associates will
receive or create protected health information (PHI) on behalf of the contractor, the contractor shall
obtain satisfactory assurances from its business associate that the business associate will appropriately
safeguard the protected health information. The satisfactory assurances must be in writing, whether in
the form of a contract or other agreement between the Contractor and the business associate. Inthe
event of a suspected or known security or privacy breach, in addition to following the procedures set
forth in 45 C.F.R. Part 164, the contractor shall also immediately notify the NIH via the Contracting
Officer (CO)and the Contracting Officer’s Representative (COR).
o. The parties agree to address HHS Information Security and Privacy Requirements, as applicable, during
definitization of the contract.
Contract number: 75N92020C00009 Page3
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
ARTICLE C.1. STATEMENT OF OBJECTIVES
Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services,
qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed
to perform the Statement of Objectives, dated July 27, 2020, setforthin SECTION J —List of Attachments,
attached hereto and made a part of this Leter Contract. Work to be performed shall be consistent with the
application and preliminary work file submitted by the Contractor and subsequent documentation submitted
during the application review process and the discussions between the parties that have taken place between
date of application submission through Letter Contract issuance.
ARTICLE C.2. REPORTING REQUIREMENTS
All reports required herein shall be submitted in electronic format only. All electronic reports submitted shall be
compliant with Section 508 of the Rehabilitation Act of 1973. Additionalinformation about testing documents
for Section 508 compliance, including guidance and specific checklists, by application, can be found at:
http://www.hhs.gov/web/508/index.html under "Making Files Accessible."
Reporting requirements TBD.
Placeholder: De-identified data for NIH research database
SECTION D — PACKAGING, MARKING, AND SHIPPING
There are no additional instructions or specifications applicable to this contract other than the delivery
instructions contained herein.
SECTION E - INSPECTION AND ACCEPTANCE
a. The Contracting Officer or the duly authorized Contracting Officer’s Representative (COR) will perform
inspection and acceptance of deliverables to be performed and the milestones to be achieved.
b. Inspection and acceptance will be performed as identified in the contract requirements.
SECTION F - DELIVERIES OR PERFORMANCE ARTICLE F.1. PERIOD OF PERFORMANCE
The period of performance of the contract is anticipated to be July 30, 2020 through July 29, 2021.
ARTICLE F.2. DELIVERIES
Satisfactory performance shall be deemed to occur upon performance of the work described in the Statement of
Objectives Article in SECTION C of this Letter Contract and upon notice and acceptance by the Contracting
Officer, or the duly authorized representative, in accordance with the stated deliverables schedule.
The deliverables or documentation there of shall be submitted to the Contracting Officer or designated
Contracting Officer Representative (COR).
Contract number: 75N92020C00009 Page 4
SECTION G - CONTRACT ADMINISTRATION DATA
ARTICLE G.1. CONTRACTING OFFICER (CO)
The following Contracting Officer (CO) will represent the Government for the purpose of this contract:
Name: Roxane Burkett
Telephone: 301-827-7535
Email: burkettr@nih.nhibi.gov
The Contracting Officeris the only person with authority to act as agent of the Government
under this task order. Only the Contracting Officer has authority to:
1) direct or negotiate any changes in the statement of work;
2) modify or extend the period of performance;
3) change the delivery schedule;
4) authorize reimbursement to the Contractor for any costs incurred during the performance of this
contract;
5) otherwise change any terms and conditions of this contract; or
6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in
Section K of the contract.
All correspondence (including invoices) that proposes or otherwise involves waivers, deviations, or
modifications to requirement shall be provided to the CO issuing the task order and the COR supporting the CO.
ARTICLE G.2. CONTRACTING OFFICER'S REPRESENTATIVE (COR)
The following Contracting Officer's Representative (COR) is anticipated to represent the Government forthe
purpose of this contract:
Olga Hartman, PhD
Telephone: 443-350-7696
Email: olga.hartman.civ@mail.mil
The COR is responsible for:
(1) monitoring the Contractor's technical progress, including the surveillance and assessment of
performance and recommending to the Contracting Officer changes in requirements;
(2) interpreting the Statement of Objectives and any other technical performance requirements;
(3) performing technical evaluation as required;
(4) performing technical inspections and acceptances required by this Letter Contract; and
(5) assisting in the resolution of technical problems encountered during performance.
The Government may unilaterally change the COR designation.
ARTICLE G.3. PRIMARY PROGRAM MANAGER
The Primary Program Manager specified in this task order is considered to be essential to work
performance. At least 30 days prior to any changes to the individual listed below to other programs or task
orders (or as soonas reasonably possible, if an individual must be replaced, forexample, asa result of
Contract number: 75N92020C00009 Page5S
leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit
comprehensive justification for the change request (including proposed substitutions for primary program
manager) to permit evaluation by the Government of the impact on performance under this task order.
The Contractor shall not replace any primary program manager without the written consent of the
Contracting Officer. The Government may modify the task order to add or delete primary program
manager at the request of the contractor or Government. In no case shall the individual’s effort exceed
100% across all task orders.
PP? eniorvice President, Operations
ne ice President, R&D & PMO, Genomics
ARTICLE G.4. INVOICE SUBMISSION
In addition to the requirements specified in FAR 32.905 fora proper invoice, the Contractor shall include
the following information on the face page of all task order payment requests:
a. The Contract Title is: “Rapid Acceleration of Diagnostics (RADx) Program: Tech Project # 6114 Fluidigm —
Advanta Dx SARS-CoV-2 RT-PCR Assay for Saliva”
b. The Contract Line Items are defined within the Section 20. Schedule of Supplies/Services of the Standard
Form 1449.
c. Invoice Instructions are attached and made part of this task order. The Contractor shall follow the
attached instructions and submission procedures specified below to meet the requirements of a"proper
invoice" pursuant to FAR Subpart 32.9, Prompt Payment.
1. Paymentrequests shall be submitted to the offices identified below. Do not submit supporting
documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your payment request unless
specified elsewhere in the contract or requested by the Contracting Officer.
a. One copy of the invoice shall be submitted to the approving official at the following email
addresses:
NHLBI Branch B Central Mailbox (NHLBIContractsBranchB@mail.nih.gov)
NIH centralized invoice email box: invoicing@nih.gov
2. E-Mail: The Contractor shall submit an electronic copy of the payment request to the approving official
instead of a paper copy. The payment request shall be transmitted as an attachment via e-mail to the
address listed above in one of the following formats: MSWord, MS Excel, or Adobe Portable
Document Format (PDF). Only one payment request shall be submitted per e-mailand the subject line
of the e-mail shall include the Contractor's name, contract number, and unique invoice number.
3. In addition to the requirements specified in FAR 32.905 fora proper invoice, the Contractor shall
include the following information on the face page of all payment requests (invoices):
a. Name ofthe Office of Acquisitions. The Office of Acquisitions for this task order is NHLBI.
b. Central Point of Distribution. For the purpose of this Task Order, the Central Point of Distribution
is NHLBI Branch B Invoices.
c. Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall
identify the Vendor Identification Number (VIN) onthe payment request. The VIN is the number
that appears after the Contractor's name on the face page of the contract. [Note: A VINis
Contract number: 75N92020C00009 Page 6
assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to
include the VINnumber.] \f the Contractor has neither a TIN, DUNS, or VIN, contact the
Contracting Officer.
d. DUNSor DUNS+4Number. The DUNS number must identify the Contractor's name and address
exactly as stated in the contract and as registered in the Central Contractor Registration (CCR)
database. If the Contractor does not have a valid DUNS number, it shall identify the Vendor
Identification Number (VIN) onthe payment request. The VIN is the number that appears after
the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts
awarded on orafter June 4, 2007, and any existing contract modified to include the VIN
number.] \f the Contractor has neithera TIN, DUNS, or VIN, contact the Contracting Officer.
e. Invoice Matching Option. This Task Order requires a two-way match.
f. Unique Invoice Number. Each payment request must be identified by a unique invoice number,
which can only be used one time regardless of the number of contracts or orders held by an
organization.
g. PRISM/NBS Line Item Number and associated PRISM/NBS Line Item Period of Performance (see SF
1449, Attachment #2).
d. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-6088.
SECTION H - ADDITONAL CONTRACT CLAUSES
ARTICLE H.1. CONFIDENTIALITY OF INFORMATION
a. Confidential information, as used in this article, means information or data of a personal
nature about an individual, or proprietary information or data submitted by or pertaining
to an institution or organization.
b. The Contracting Officerand the Contractor may, by mutual consent, identify elsewhere in this
contract specific information and/or categories of information which the Government will
furnish to the Contractor or that the Contractor is expected to generate which is confidential.
Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such
confidential information from time to time during the performance of the contract. Failure to
agree will be settled pursuant to the "Disputes" clause.
c. Ifit is established elsewhere in this contract that information to be utilized under this contract, or
a portion thereof, is subject to the Privacy Act, the Contractor will follow the rules and procedures
of disclosure set forth in the Privacy Act of 1974, 5 U.S.C.552a, andimplementing regulations and
policies, with respect to systems of records determined to be subject to the Privacy Act.
d. Confidential information, as defined in paragraph (a) of this article, shall not be disclosed without
the prior written consent of the individual, institution, or organization.
e. Wheneverthe Contractor is uncertain with regard to the proper handling of material under the
contract, or if the material in question is subject to the Privacy Act or is confidential information
subject to the provisions of this article, the Contractor should obtain a written determination
Contract number: 75N92020C00009 Page7
from the Contracting Officer prior to any release, disclosure, dissemination, or publication.
f. Contracting Officer determinations will reflect the result of internal coordination with
appropriate program and legalofficials.
g. The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping
provisions in other Federal, State or local laws.
ARTICLE H.2. PUBLICATION AND PUBLICITY
In addition to the requirements set forth in HHSAR Clause 352.227-70, Publications and Publicity
incorporated by reference in SECTION | of this contract, the Contractor shall acknowledge the support
of the National Institutes of Health whenever publicizing the work under this contract in any media
by including an acknowledgment substantially as follows:
"This project has been funded in whole or in part with Federal funds from the National Institutes
Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health and
Human Services, under Contract No: 75N92020C00009.”
ARTICLE H.3. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE
Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in
NIH funded programs is encouraged to report such matters to the HHS Inspector General's Office
in writing or on the Inspector General's Hotline. The toll free number is 1-800-HHS-TIPS (1-800-
447-8477). All telephone calls will be handled confidentially. The website to file a complaint on-
line is: http://oig.hhs.gov/fraud/hotline/ and the mailing address is:
US Department of Health and Human Services Office of Inspector
General
ATTN: OIG HOTLINE OPERATIONS
P.O. Box 23489 Washington, D.C. 20026
PART II - CONTRACT CLAUSES SECTION | - CONTRACT CLAUSES
Selections will be made by the Contracting Officer during definitization
ARTICLE 1.1. ADDITIONAL CONTRACT CLAUSES
This contract incorporates the following clauses by reference, (unless otherwise noted), with the same force and
effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.
FAR Clause 52.212-3 Offeror Representations and Certifications — Commercial Items (Jun 2020)
FAR Clause 52.212-4 Contract Terms and Conditions — Commercial Items (Oct 2018)
FAR Clause 52.203-13, Contractor Code of Business Ethics and Conduct (October 2015)
FAR Clause 52.204-2, Security Requirements (August 1996).
FAR Clause 52.204-9, Personal ldentity Verification of Contractor Personnel (January 2011).
FAR Clause 52.204-13, System for Award Management Maintenance
FAR Clause 52.204-18 Commercial and Government Entity Code Maintenance (July 2016)
FAR Clause 52.204-23 Prohibition on Contracting for Hardware, Software, and Services Developed or
Provided by Kaspersky Lab and Other Covered Entities
mmoao ToD
Contract number: 75N92020C00009 Page 8
h. FAR Clause 52.209-10, Prohibition on Contracting With Inverted Domestic Corporations(November
2015).
i. FAR Clause 52.222-4, Contract Work Hours and Safety Standards - Overtime Compensation -General
(May 2014).
FAR Clause 52.222-29, Notification of Visa Denial (April 2015).
FAR Clause 52.223-15, Energy Efficiency in Energy-Consuming Products (December 2007).
FAR Clause 52.224-1, Privacy Act Notification (April 1984).
. FAR Clause 52.224-2, Privacy Act (April 1984).
FAR Clause 52.227-1, Aughorization and Consent (Jun 2020).
FAR Clause 52.227-3 Patent Indemnity (Apr 1984).
FAR Claus 52.227-11 Patent Rights-Ownership by the Contractor (May 2014).
FAR Clause 52.227-14, Rights in Data - General (May 2014).
FAR Clause 52.227-14, Rights in Data - General (May 2014) Alternate II (Dec 2007).
FAR Clause 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)
yraposguRy
ARTICLE 1.3. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT
a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES
Additional clauses other than those listed below which are based on the type of contract/Contractor
shall be determined during definitization. This contract incorporates the following clauses in full text.
1. FAR 52.216-23 - EXECUTION AND COMMENCMENT OF WORK (APR 1984)
The Contractor shall indicate acceptance of this letter contract by signing One Copy of the contract
and returning them to the Contracting Officer not later than July 29, 2020 at 4:00 p.m. Eastern. Upon
acceptance by both parties, the Contractor shall proceed with performance of the work, including
purchase of necessary materials.
2. FAR 52.216-24 - LIMITATION OF GOVERNMENT LIABILITY (APR 1984)
(a) In performing this contract, the Contractor is not authorized to make expenditures orincur
obligations exceeding $12,151,000 dollars.
(b) The maximum amount for which the Government shallbe liable if this contract is terminated is
$12,151,000 dollars.
3. FAR52.216-25 - CONTRACT DEFINITIZATION (OCT 2010)
(a) A Firm Fixed Price (FFP) definitive contract is contemplated. The Contractor agrees to begin promptly
negotiating with the Contracting Officer the terms of a definitive contract that will include (1) all clauses
required by the Federal Acquisition Regulation (FAR) on the date of execution of the letter contract, (2) all
clauses required by law on the date of execution of the definitive contract, and (3) any other mutually
agreeable clauses, terms, and conditions. The Contractor agrees to submit a Firm Fixed Price proposal,
including data other than certified cost or pricing data, and certified cost or pricing data, in accordance with
FAR 15.408, Table 15-2, supporting its proposal.
(b) The schedule for definitizing this contract is as follows:
Estimated date for start of negotiations: 8/3/2020
Target date for definitization: 9/25/2020
[ Definitization Schedule [Date
Contract number: 75N92020C00009 Page9
Statement of Work Review 7/27/2020
Issuance of Letter Contract 7/30/2020
Letter Contract Post Award Kick Off meeting 7/31/2020
Contractor Price Proposal Submittal 8/5/2020
Business and Technical Review 8/12/2020
Negotiations Start 8/13/2020
Request Budget and Price Breakdown 9/7/2020
Definitization of Letter Contract 9/25/2020
(c) Ifagreement ona definitive contract to supersede this letter contract is not reached by the target
date in paragraph (b) of this section, or within any extension of it granted by the Contracting
Officer, the Contracting Officer may, with the approval of the head of the contracting activity,
determine areasonable price or fee in accordance with subpart 15.4 and part 31 of the FAR,
subject to Contractor appeal as provided in the Disputes clause. In any event, the Contractor shall
proceed with completion of the contract, subject only to the Limitation of Government Liability
clause.
(1) Afterthe Contracting Officer’s determination of price or fee, the contract shall be governed
by-
(i) All clauses required by the FAR on the date of execution of this letter contract for
either fixed-price or cost-reimbursement contracts, as determined by the Contracting
Officer under this paragraph (c);
(ii) All clauses required by law as of the date of the Contracting Officer’s determination;
and
(iii) Any other clauses, terms, and conditions mutually agreed upon.
(2) To the extent consistent with paragraph (c)(1) of this section, all clauses, terms, and
conditions included in this letter contract shall continue in effect, except those that by their
nature apply only to a letter contract.
4, FAR Clause 52.204-21, Basic Safeguarding of Covered Contractor Information Systems (Jun 2016)
(a) Definitions. As used in this clause—
Covered contractor information system means an information system that is owned or
operated bya contractor that processes, stores, or transmits Federal contract
information.
Federal contract information means information, not intended for public release, that is
provided by or generated for the Government under a contract to develop or delivera
product or service to the Government, but not including information provided by the
Governmentto the public (such as on public websites) orsimple transactional
information, such as necessary to process payments.
Information means any communication or representation of knowledge such as facts,
data, or opinions, in any medium or form, including textual, numerical, graphic,
cartographic, narrative, or audiovisual (Committee on National Security Systems
Instruction (CNSSI) 4009).
Contract number: 75N92020C00009 Page 10
Information system means a discrete set of information resources organized for the
collection, processing, maintenance, use, sharing, dissemination, or disposition of
information (44 U.S.C. 3502).
Safeguarding means measures or controls that are prescribed to protect information
systems.
(b) Safeguarding requirements and procedures.
(1) The Contractor shall apply the following basic safeguarding requirements and
procedures to protect covered contractor information systems. Requirements and
procedures for basic safeguarding of covered contractor information systems shall
include, at a minimum, the following security controls:
i) Limit information system access to authorized users, processes acting on behalf of
authorized users, or devices (including other information systems).
ii) Limit information system access to the types of transactions and functions that
authorized users are permitted to execute.
iii) Verify and control/limit connections to and use of externalinformation systems.
iv) Control information posted or processed on publicly accessible information
systems.
'v) Identify information system users, processes acting on behalf of users, or devices.
vi) Authenticate (orverify) the identities of those users, processes, or devices, asa
prerequisite to allowing access to organizational information systems.
vii) Sanitize or destroy information system media containing Federal Contract
Information before disposal or release for reuse.
viii) Limit physical access to organizational information systems, equipment, and the
respective operating environments to authorized individuals.
ix) Escort visitors and monitor visitor activity; maintain audit logs of physical access;
and control and manage physical access devices.
x) Monitor, control, and protect organizational communications (i.e., information
transmitted or received by organizational information systems) at the external
boundaries and key internal boundaries of the information systems.
xi) Implement subnetworks for publicly accessible system components that are
physically or logically separated from internal networks.
xii) Identify, report, and correct information and information system flaws in a timely
manner.
Contract number: 75N92020C00009 Page 11
(xiii) Provide protection from malicious code at appropriate locations within
organizational information systems.
(xiv) Update malicious code protection mechanisms when new releases are available.
(xv) Perform periodic scans of the information system and real-time scans of files from
externalsources as files are downloaded, opened, or executed.
(2) Other requirements. This clause does not relieve the Contractor of any other specific
safeguarding requirements specified by Federal agencies and departments relating to
covered contractor information systems generally or other Federalsafeguarding
requirements for controlled unclassified information (CUI) as established by Executive
Order 13556.
(c) Subcontracts. The Contractor shall include the substance of this clause, including this
paragraph (c), in subcontracts under this contract (including subcontracts for the
acquisition of commercial items, other than commercially available off-the-shelf items), in
which the subcontractor may have Federal contract information residing in or transiting
through its information system.
(End of clause)
5. FAR52.214-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-
Commercial Items (Jul 2020)
(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses,
which are incorporated in this contract by reference, toimplement provisions of law or
Executive orders applicable to acquisitions of commercial items:
(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or
Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further
Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in
subsequent appropriations acts (and as extended in continuing resolutions)).
(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or
Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L.
115-91).
(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video
Surveillance Services or Equipment. (Aug 2019) (Section 889(a)(1)(A) of Pub. L. 115-
232).
(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov
2015).
(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).
(6) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and
108-78 ( 19 U.S.C. 3805 note)).
Contract number: 75N92020C00009 Page 12
(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting
Officer has indicated as being incorporated in this contract by reference to implement
provisions of law or Executive orders applicable to acquisitions of commercial items. Selections
will be made by the Contracting Officer during definitization:
__ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (JUNE 2020),
with Alternate I (Oct 1995) ( 41U.S.C.4704 and 10 U.S.C. 2402).
__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509)).
__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment
Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the
American Recovery and Reinvestment Act of 2009.)
__ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN
2020) (Pub. L. 109-282) ( 31 U.S.C. 6101 note).
___(5) [Reserved].
__ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section
743 of Div. C).
__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery
Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).
__ (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors
Debarred, Suspended, or Proposed for Debarment. (JUN 2020) (31 U.S.C. 6101 note).
___(9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (OcT
2018) (41 U.S.C. 2313).
___(10) [Reserved].
___(11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (MAR
2020) (15 U.S.C. 657a).
___(ii) Alternate | (Mar 2020) of 52.219-3.
__ (12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business
Concerns (Mar 2020) (if the offeror elects to waive the preference, it shall so indicate in its
offer) (15 U.S.C. 657a).
___ (ii) Alternate | (Mar 2020) of 52.219-4.
___(13) [Reserved]
__ (14) (i) 52.219-6, Noti
6 (15 U.S.C. 644).
ice of Total Small Business Set-Aside (Mar 2020) of 52.219-
__(ii) Alternate |
__ (15) (i) 52.219-7, Notit
__(ii) Alternate |
___ (16) 52.219-8, Utilizati
__ (17) (i) 52.219-9, Smal
__ (ii) Alternate!
__ (iii) Alternate |
___(iv)Alternate II
Mar 2020) of 52.219-6 .
ice of Partial Small Business Set-Aside (Mar 2020) (15 U.S.C. 644).
Mar 2020) of 52.219-7.
ion of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).
Il Business Subcontracting Plan (Jun 2020) (15 U.S.C. 637(d)(4)).
Nov 2016) of 52.219-9.
1 (Nov 2016) of 52.219-9.
I (Jun 2020) of 52.219-9.
__ (v)AlteRNATEIV (JUN 2020) oF 52.219-9
__ (18) (i) 52.219-13, Noti
___(ii) Alternate |
__(19) 52.219-14, Limita
__ (20) 52.219-16, Liquid
ice of Set-Aside of Orders (Mar 2020) (15 U.S.C. 644(r)).
Mar 2020) of 52.219-13.
tions on Subcontracting (Mar 2020) (15 U.S.C. 637(a)(14)).
lated Damages-Subcontracting Plan (Jan
1999) (15 U.S.C. 637(d)(4)(F)(i)).
___(21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Mar
Contract number: 75N92020C00009 Page 13
2020) (15 U.S.C. 657f).
___ (22) (i) 52.219-28, Post Award Small Business Program Rerepresentation (May
2020) (15 U.S.C. 632(a)(2)).
__ (ii) Alternate | (MAR 2020) of 52.219-28.
__ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged
Women-Owned Small Business Concerns (Mar 2020) (15 U.S.C. 637(m)).
__ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small
Business Concerns Eligible Under the Women-Owned Small Business Program (Mar2020)
(15 U.S.C. 637(m)).
___ (25) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020)(15 U.S.C.
644(r)).
___ (26) 52.219-33, Nonmanufacturer Rule (Mar 2020) (15U.S.C. 637(a)(17)).
__ (27) 52.222-3, Convict Labor (Jun 2003) (E.0.11755).
__ (28) 52.222-19, Child Labor- Cooperation with Authorities and Remedies (Jan2020)
(E.0.13126)
___ (29) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).
__ (30) (i) 52.222-26, Equal Opportunity (Sep 2016) (E.0.11246).
__(ii) Alternate | (Fes 1999) of 52.222-26.
__ (31) (i) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).
___ (ii) Alternate | (JUL2014) of 52.222-35.
__ (32) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).
__ (ii) Alternate | (Jut 2014) of 52.222-36.
___(33) 52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).
__ (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec
2010) (E.0. 13496).
__ (35) (i) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.O.
13627).
__ (ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).
__ (36) 52.222-54, Employment Eligibility Verification (Oct 2015). (Executive Order 12989). (Not
applicable to the acquisition of commercially available off-the-shelf items or certain other
types of commercial items as prescribed in 22.1803.)
___(37) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA—Designated
Items (May 2008) ( 42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of
commercially available off-the-shelf items.)
__(ii) Alternate | (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the
acquisition of commercially available off-the-shelf items.)
__ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential
Hydrofluorocarbons (Jun 2016) (E.0. 13693).
__ (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air
Conditioners (Jun 2016) (E.O. 13693).
__ (40) (i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.0.s
13423 and 13514).
__(ii) Alternate | (Oct 2015) of 52.223-13.
___ (41) (i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s 13423 and
13514).
___ (ii) Alternate | (Jun2014) of 52.223-14.
__ (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (May
2020) (42 U.S.C. 8259b).
Contract number: 75N92020C00009 Page 14
___ (43) (i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (Oct
2015) (E.0.s 13423 and 13514).
___(ii) Alternate | (JUN 2014) of 52.223-16.
_ (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun
2020) (E.O. 13513).
___ (45) 52.223-20, Aerosols (Jun 2016) (E.0. 13693).
___ (46) 52.223-21, Foams (Jun2016) (E.0. 13693).
__ (47) (i) 52.224-3 Privacy Training (JAN 2017) (5 U.S.C. 552 a).
__ (ii) Alternate | (JAN 2017) of 52.224-3.
__ (48) 52.225-1, Buy American-Supplies (May 2014) (41 U.S.C. chapter 83).
__ (49) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (May
2014) (41 U.S.C.chapter83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19
U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-
283, 110-138, 112-41, 112-42, and 112-43.
__(ii) Alternate | (May 2014) of 52.225-3.
___(iii) Alternate Il (May 2014) of 52.225-3.
___(iv) Alternate III (May 2014) of 52.225-3.
___(50) 52.225-5, Trade Agreements (Oct 2019) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).
__ (51) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.0.’s, proclamations,
and statutes administered by the Office of Foreign Assets Control of the Department of the
Treasury).
___(52) 52.225-26, Contractors Performing Private Security Functions Outside the United States
(Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal
Year 2008; 10 U.S.C. 2302Note).
__ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov2007) (42 U.S.C. 5150).
___ (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov2007)
(42 U.S.C. 5150).
__ (55) 52.229-12, Tax on Certain Foreign Procurements (JUN 2020).
__ (56) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb
2002) (41 U.S.C. 4505, 10 U.S.C. 2307/(f)).
__ (57) 52.232-30, Installment Payments for Commercial Items (Jan2017)
(41 U.S.C. 4505, 10 U.S.C. 2307(f)_ (58) 52.232-33, Payment by Electronic Funds Transfer-
System for Award Management (Oct2018) (31 U.S.C. 3332).
__ (59) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award
Management (Jul 2013) (31 U.S.C. 3332).
__ (60) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).
___(61) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).
___ (62) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(13)).
__ (63) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (FEB
2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).
___(ii) Alternate | (Apr 2003) of 52.247-64.
___ (iii) Alternate II (Fes 2006) of 52.247-64.
(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial
services, that the Contracting Officer has indicated as being incorporated in this contract by
reference to implement provisions of law or Executive orders applicable to acquisitions of
commercial items:
__ (1) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter67).
___(2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May
Contract number: 75N92020C00009 Page 15
2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).
___(3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price
Adjustment (Multiple Year and Option Contracts) (Aug
2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).
__ (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price
Adjustment (May 2014) ( 29U.S.C.206 and 41 U.S.C. chapter 67).
__ (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to
Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May
2014) (41 U.S.C. chapter 67).
__ (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to
Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67).
___(7) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).
(8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.0. 13706).
__ (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020)
(42.U.S.C. 1792).
(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of
this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the
simplified acquisition threshold, as defined in FAR 2.101, on the date of award of this contract,
and does not contain the clause at 52.215-2, Audit and Records-Negotiation.
(1) The Comptroller General of the United States, or an authorized representative of the
Comptroller General, shall have access to and right to examine any of the Contractor’s
directly pertinent records involving transactions related to this contract.
(2) The Contractor shall make available at its offices at all reasonable times the records,
materials, and other evidence for examination, audit, or reproduction, until 3 years after
final payment under this contract or for any shorter period specified in FAR subpart 4.7,
Contractor Records Retention, of the other clauses of this contract. If this contract is
completely or partially terminated, the records relating to the work terminated shall be
made available for 3 years after any resulting final termination settlement. Records relating
to appeals under the disputes clause or to litigation or the settlement of claims arising under
or relating to this contract shall be made available until such appeals, litigation, or claims are
finally resolved.
(3) As usedin this clause, records include books, documents, accounting procedures and
practices, and other data, regardless of type and regardless of form. This does not require
the Contractor to create or maintain any record that the Contractor does not maintain in
the ordinary course of business or pursuant to a provision of law.
(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this
clause, the Contractor is not required to flow down any FAR clause, other than those in this
paragraph (e)(1) ina subcontract for commercial items. Unless otherwise indicated below, the
extent of the flow down shall be as required by the clause-
(i) 52.203-13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509).
(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or
Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further
Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in
subsequent appropriations acts (and as extended in continuing resolutions)).
Contract number: 75N92020C00009 Page 16
(iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or
Provided by Kaspersky Lab and Other Covered Entities (JUL 2018) (Section 1634 of Pub. L.
115-91).
(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video
Surveillance Services or Equipment. (AuG 2019) (Section 889(a)(1)(A) of Pub. L. 115-232).
(v) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)), in
all subcontracts that offer further subcontracting opportunities. If the subcontract (except
subcontracts to small business concerns) exceeds the applicable threshold specified in
FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219-
8 in lowertier subcontracts that offer subcontracting opportunities.
(vi) 52.222-21, Prohibition of Segregated Facilities (APR 2015).
(vii) 52.222-26, Equal Opportunity (Sep 2015) (E.0.11246).
(viii) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).
(ix) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).
(x) 52.222-37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).
(xi) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec
2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR
clause 52.222-40.
(xii) 52.222-41, Service Contract Labor Standards (Aug2018) (41 U.S.C. chapter 67).
(xiii) (A) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.O
13627).
(B) Alternate | (Mar2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).
(xiv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to
Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements
(May2014) (41 U.S.C. chapter 67).
(xv) 52.222-53, Exemption from Application of the Service Contract Labor Standards to
Contracts for Certain Services-Requirements (MAyY2014) (41 U.S.C. chapter 67).
(xvi) 52.222-54, Employment Eligibility Verification (Oct 2015) (E.0. 12989).
(xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).
(xviii) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).
(xix) (A) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).
(B) Alternate | (Jan 2017) of 52.224-3.
(xx) 52.225-26, Contractors Performing Private Security Functions Outside the United
States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for
Fiscal Year 2008; 10 U.S.C. 2302 Note).
(xxi) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun
2020) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR
clause 52.226-6.
(xxii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb
2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance
with paragraph (d) of FAR clause 52.247-64.
(2) While not required, the Contractor may include in its subcontracts for commercial items a
minimal number of additional clauses necessary to satisfy its contractual obligations.
(End of clause)
Contract number: 75N92020C00009 Page 17
PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS
SECTION J LIST OF ATTACHMENTS
1. Statement of Objectives
i. Appendix 1: Contract Deliverables
Contract number: 75N92020C00009 Page 18
Attachment 1 — Statement of Objectives
Statement of Objectives
Program Title: Rapid Acceleration of Diagnostics (RADx)—Tech
Project Title: Rapid Acceleration of Diagnostics (RADx) Program: Tech Project #6114 Fluidigm — Advanta Dx
SARS-CoV-2 RT-PCR Assay for Saliva
Agency: National Institute of Biomedical Imaging and Bioengineering (NIBIB) / National Institutes of Health
(NIH)
1. Background
The National Institute of Biomedical Imaging and Bioengineering (NIBIB) has arequirement for proposals to
provide up to $500 million across multiple projects to rapidly produce innovative SARS-CoV-2 diagnostic
tests that will assist the public’s safe return to normal activities. Rapid Acceleration of Diagnostics (RADx), is
a fast-track technology development program that leverages the National Institutes of Health (NIH) Point-of-
Care Technology Research Network (POCTRN). RADx will support novel solutions that build the U.S. capacity
for SARS-CoV-2 testing up to 100-fold above what is achievable with standard approaches. RADx is
structured to deliver innovative testing strategies to the public as soonas late summer 2020 and is an
accelerated and comprehensive multi-pronged effort by NIH to make SARS-CoV-2 testing readily available to
every American.
2. Purpose and Objectives
NIBIBis providing substantial support to accelerate the development, validation, and commercialization of
innovative point-of-care and home-based tests, as well as improvements to clinical laboratory tests, that can
directly detect SARS-CoV-2, the virus that causes COVID-19. NIBIB will support the full range of product
development including commercialization and product distribution. The ultimate goal of the RADx program
— across multiple projects/contracts—is to make millions of tests per week available to the American public,
particularly those most vulnerable to and/or disproportionately impacted by COVID-19, in the late summer
of 2020, and having even more tests available in time for the 2020-2021 flu season.
To meet the accelerated timelines, RADx has assembled a national network of expert technical, clinical,
manufacturing, and regulatory advisors who will provide individualized assistance for project development
and commercialization. Funding for projects selected for this program will be dependent on successfully
meeting aggressive project milestones. Through the POCTRN grants, NIBIB provides financial and in-kind
support to accelerate the entire product life-cycle, from design to market, for projects that meet milestones
successfully. To ensure that innovations are available to the public as quickly as possible, NIH will leverage
established partnerships with federal agencies, such as FDA, CDC, CMS, ASPR/BARDA, the Department of
Defense, as wellas commercial and private entities to propel technologies developed by RADx into
widespread use.
The RADx program will consider innovations at all stages of readiness to circumvent current limitations to
SARS-CoV-2 testing capacity, including:
— Early stage: transformative innovations based on novel testing strategies that have potential for
major scale up
— Mid stage: technologies using novel testing strategies that have demonstrated capability but need
further validation, regulatory approval, and scale up
— Advanced stage (RADx ATP): modification and optimization of existing SARS-CoV-2 testing
approaches, including clinical laboratory tests, that can dramatically increase testing capacity. Note:
This arm of the RADx program is addressed under a separate Acquisition Plan.
Page 1 of 3
Attachment 1 — Statement of Objectives
Design features might include technical innovations that:
Improve analytical performance, e.g., sensitivity, specificity, dynamic range, limit of detection,
reliability, accuracy, speed (time to test result) and throughput
Enhance operational performance through, e.g., development of a patient- and user-friendly design,
use of alternative sampling strategies (e.g., saliva, exhaled breath), integration with mobile-devices,
designs for home-based use or strategies to overcome bottlenecks with current testing approaches
Improve access and reduce the cost of testing.
3. Scope
RADx-Tech is a two-phase program. Allapplications undergo an intensive week-long risk assessment by a
panel of expert technical, clinical, manufacturing, and regulatory advisors. If the proposed technology meets
viability metrics, projects may be selected to enter phase one.
Phase one, performed under a separate funding mechanism, consists of an accelerated research and
development program in which the awardee receives both financial support and in-kind services through
RADx grant funding. This outcome of this work is a fully instantiated technology ready for clinical validation,
regulatory authorization, production and commercialization.
Phase two, or Work Package 2, of the program, executed under this contract, includes completing the
validation, approval, and production processes in order to delivera viable productin a scaled up capacity to
the U.S. public.
4. Performance Objectives (Required Results)
A. Contract recipients have completed major research and development efforts and are focused in phase
twoon completion of required clinical validation, preparation of regulatory submissions, scale-up of
production capabilities, and preparation for full commercialization of their product —a testing
technology. Every contract will encompass similar expectations and milestones concerned with:
1.
2.
3.
4
meeting regulatory requirements, resulting in regulatory authorization for sale and use of the test;
instantiation of agreed-upon production capacity;
meeting agreed-upon production goals; and
implementation of an agreed-upon commercial strategy to bring the test to marketin a timeframe
that will impact the COVID-19 pandemicas soon as possible.
B. Contract funding in phase two is structured in order to reduce risk to the Government, and is dependent
on achievement of specific milestones in the Schedule of Deliverables, according to the Payment
Schedule.
C. The contractor must use a SARS-Cov-2 test with FDA EUA (or will have EUA near the time of award),
indicating a combination of sensitivity, specificity, and usability appropriate to the intended use
according to FDA and/or CDC guidance, as applicable.
D. The contractor must make the product available fora confidential independent regulatory/validation
assessment. The independent assessor will be selected by the Government and specified in the
contract.
E.
The contractor must provide a risk mitigation plan for each identified risk and update and inform
Page 2 of 3
Attachment 1 — Statement of Objectives
NIH onany changes/newly identified risks inan ongoing manner.
5. Contract Type
The contract type is Firm Fixed Price.
6. Place of Performance
Place of Performance will be at the contractor’s site(s).
7. Period of Performance
The period of performance of the contract is anticipated to be July 30, 2020 through July 29, 2021.
8. Deliverables/Delivery Schedule
See the attached Appendix 1: Schedule of Deliverables.
9. Other Requirements
A. The contractor must meet regularly (at least weekly) with NIH officials to update on progress toward
deliverables; anticipated and ongoing issues and problems; and timelines for deliverable completion.
When guided by NlH officials, the contractor must be willing to collaborate and cooperate under
reasonable confidentiality terms with external organizations as needed to meet the contract goals ina
manner which will not infringe contractor commercial or intellectual property rights.
Page 3 of 3
Appendix 1 - Deliverables
8
SubTasks
No.
Objective
Defined
bya)
Milestone Defined
Deliverable
From: Stevens, Ashley J [astevens@bu.edu]
Sent: 4/4/2017 4:11:42 PM
To: Rohrbaugh, Mark (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/cn=OD/cn=ROHRBAUM)
Subject: RE: data on university TT income
Attachments: Abrams, Leung and Stevens.pdf
One of mine, published in 2009 with the data from 2006.
“How US Academic Licensing Offices are Tasked and Motivated — Is it all about the money?”, Irene Abrams,
Grace Leung and Ashley Stevens, Research Management Review, 17.1, Fall/Winter 2009;
Nothing since, but | have modeled it from the AUTM data once or twice — you have Net Income and can assume 25%
kept for expenses. You have Net Patent Expenses. You have staffing numbers and can assume a mix and get salary
levels from the AUTM salary survey, add 26% for overhead and 10% for all other office expenses. When you do that, the
numbers look pretty similar to the 2006 data.
Best wishes,
Ashley Stevens
Focus IP Group, LLC
Winchester, MA
o@®
From: Rohrbaugh, Mark (NIH/OD) [E] [mailto:RohrBauM@od.nih.gov]
Sent: Tuesday, April 4, 2017 11:42 AM
To: Stevens, Ashley J <astevens@bu.edu>
Subject: data on university TT income
Ashley:
The data you presented at KEI on the % of TTOs that cover costs and ranges of income was helpful. Is that in print
somewhere or available from AUTM?
Thanks,
Mark
Mark L. Rohrbaugh, Ph.D., J.D.
Special Advisor for Technology Transfer
Director, Division of Technology Transfer and Innovation Policy
Office of Science Policy
Office of the Director
National Institutes of Health
Research Management Review, Volume 17, Issue 1
Fall/Winter 2009
How are U.S. Technology Transfer Offices
Tasked and Motivated—
Is It All About the Money?
Irene Abrams
Brandeis University
Grace Leung
Harvard University
Ashley J. Stevens
Boston University
ABSTRACT
We conducted a survey of directors of offices of technology transfer (TTOs) at U.S. academic
institutions to determine how they are organized, tasked, financed, and motivated. We found some
interesting quantitative data that have not been reported previously: (1) academic institutions spend on
average 0.6% of their research budgets on transferring the technology resulting from their research
programs, split 45% on patent protection and 55% on operating costs; and (2) over half the technology
transfer programs bring in less money than the costs of operating the program, and only 16% are self-
sustaining, bringing in enough income that, after distributions to inventors and for research, there are
sufficient funds to cover the operating costs of the program. This leads to the surprising conclusion that
the Bayh-Dole Act has been an unfunded mandate on academic institutions, and that academic
institutions need to invest in their technology transfer operations in order to bring the benefits of their
research to society.
Research Management Review, Volume 17, Issue 1
Fall/Winter 2009
We found that 20.3% of institutions are required to fund 50% or more of their operating budget from the
income they generate, giving them an incentive to maximize income. The most important drivers of
technology transfer are faculty service and translating the results of research, with only 11.5% reporting
revenue maximization as the most important driver. We found that fewer than 20% of offices have
incentive compensation plans, and only 28% of the performance factors that are taken into account in
determining incentive pay are financial measures, with broader, non-financial performance measures
accounting for 70% of the factors. Finally, a surprisingly large number of institutions do not have formal
mission statements, but those that do establish broad, non-financial objectives for their offices, with only
two institutions out of eighty (2.5%) having mission statements that establish revenue maximization as
the objective of the offices.
We therefore conclude that although a small number of academic institutions have reaped very large
rewards from their technology transfer activities—close to $4 billion in transactions that we were able to
identify—these rewards appear to be a consequence of programs driven by broader objectives, and not a
driving force for technology transfer as some have recently asserted. In our assessment, fewer than 10%
of U.S. institutions’ technology transfer programs are primarily motivated by financial return.
BACKGROUND—
TECHNOLOGY TRANSFER IN THE UNITED STATES
In 1980, Congress enacted the Bayh-Dole Act! and allowed U.S. universities, teaching hospitals, and
research institutes to have the automatic right to take title to inventions developed with federal funding.
In response, these institutions have established offices to seek patent protection on these inventions and
license them to existing and new businesses for development and commercialization. Since 1991, the
Association of University Technology Managers (AUTM) has published an annual survey that has
quantified the magnitude of this enterprise’.
The AUTM annual surveys have documented important products that have resulted from Bayh-Dole, and
other studies have quantified the considerable contribution to improving public health through the
discovery, patenting, licensing, and successful development of approaching 150 small molecule and
biological drugs, vaccines, and in vivo diagnostics (Jensen et al., 2007). In addition, key components of
the Internet economy—web browsers such as Internet Explorer, portals such as Lycos, email such as
Eudora, and search engines such as Google—were based on licensed university technologies.
Certainly some institutions have garnered substantial economic returns from technology transfer. The
2008 AUTM Licensing Activity Survey showed that, overall, U.S. academic institutions received $3.4
billion in licensing income. However, as the survey results also show, this income is highly concentrated
in a small number of institutions that have had one big success, most often a drug—the so-called “big
hit”. In a relatively recent phenomenon, some of these institutions have accelerated receipt of the future
royalty streams from these “big hits” through a sale of their royalty rights to either the marketer of the
drug or to specialized investment partnerships and have received even larger, one-time “big hits”. Recent
lump sum payments have approached $1 billion. Table 1 summarizes some of these transactions and
shows that institutions and their inventors have received almost $3.5 billion from such sales since 1999,
with the pace accelerating in recent years.
Research Management Review, Volume 17, Issue 1
Fall/Winter 2009
Table 1. Major Royalty Sales by Academic Institutions and/or Their Inventors
Date Product Licensor Amount ($ million)
June 1990 Neupogen Amgen $75
Dec. 1999 Zerit Yale University! $125
Jan. 2001 Thalomid Children’s Hospital $5
Sept. 2003 Aldurazyme LA Biomed” $25,
Jan. 2004 Neupogen/Neulasta (U.S.) Memorial-Sloan Kettering’ $263
Jan. 2005 Macugen University of Colorado* $45
Jan. 2005 Rotarix Children’s Hospital Cincinnati* na ae
Jan. 2005 Rotateq Wistar Institute® $45 *
July 2005 Emtriva Emory University’ $525
Aug. 2005 Remicade NYU/Dr. Vilcek $46 +*
Aug. 2005 Neupogen/neulasta (Non-U.S.) Memorial-Sloan Kettering* $142
Oct. 2005 Humira Scripps Research Institute” $32 *
June 2006 Embrel (US) MGH” $248
April 2007 Enbrel (Foreign) MGH" $284
May 2007 Remicade New York University’? $650
July 2007 FluMist U. of Michigan'® $35
Dec. 2007 Lyrica Northwestern'* $700
Dec. 2007 Rotarix Cincinnati Children’s Hosp.'* $24
June 2008 RotaTeq Children’s Hosp. of Phil.'® $182
Total $3,451
* Estimate
** Sale by inventor
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hup://www.paulcapitalhealthcare.com/portfolio/overview.htm
http://w royaltypharma.com/media/pr/2004/MSKCC-01222004. pdf
“https://www.cu.edwitechtransfer/downloads/TechTransfer2005.paf
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http://www. boston.com/business/technology/biotechnology/articles/2007/04/19/drug_nets_284m_for_mgh
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“http: //www.royaltypharma.com/media/documents/Remicade-RoyaltyPharmaPurchaseo{RemicadeRoyaltyFromNYU.pdf
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"http://www royaltypharma.com/media/documents/rotateq. pdf
Another source of “big hits” has been sales of equity, such as Dartmouth’s $64 million sale of its equity
stake in Medarex in 2000 and Stanford’s sale of its $355 million equity stake in Google in 2005. Yet
another has been legal settlements, such as the University of California’s $200 million settlement with
Research Management Review, Volume 17, Issue 1
Fall/Winter 2009
Genentech over human growth hormone in 2000 and $30.4 million with Microsoft in 2007 over accessing
interactive content on web pages, and the 1999 settlement between the University of Minnesota and
Glaxo over Ziagen, valued at $300 million.
In spite, or perhaps because, of these financial successes, the involvement of academia in
commercializing the results of its research has been controversial. Books written on the subject have
blamed research commercialization for everything from increasing undergraduate tuition to destroying
the public’s trust in the objectivity of the advice and analysis it receives from professors (Bok, 2003;
Krimsky, 2003, Washburn, 2005). Others, however, have documented the inherent entrepreneurialism of
faculty (Shane, 2004), while others have demonstrated that only a minority of science faculty attempt to
commercialize their research (Thursby & Thursby, 2003).
However, there has been little research on why institutions invest in the resources necessary to
commercialize the results of their research. When university presidents speak publicly on the issue, they
focus more on the public’s right to see a return on the investment of their tax dollars in research grants
via the availability of new products and services, rather than on the financial return that they might hope
to see. For instance, Dr. Mary Sue Coleman, President of the University of Michigan, told the Annual
Meeting of the Association of University Technology Managers in 2005 (Coleman, 2003):
I think many people are often confused about why we are interested in technology
commercialization, in nurturing start up companies, and in facilitating more patents and license
agreements.
It is not about the promise of future revenues that might be generated from this activity.
You heard me correctly. It is not about the money.
Of course, revenue generation serves as an incentive. But first and foremost, technology transfer
must serve our core mission: sharing ideas and innovations in the service of society’s well-being.
In fact, at Michigan we expect to re-invest institutional gains back into technology transfer
efforts. Revenue generation is NOT the ultimate goal. It is simply the means by which we can
increase the transfer of new knowledge into the business sector.
A recent study by Litan, Mitchell, and Eddy of the Kauffman Foundation disputed Dr. Coleman’s views
and emphasized the role of financial incentive in technology transfer (Litan, Mitchell, & Reedy, 2007).
The Foundation’s website stated’:
The emphasis among universities to reap big financial rewards through licensing and patenting
innovation developed by research scientists is actually impeding the development of new
technologies and may be masking the importance of other means of knowledge transfer.
The study went on to claim that universities are motivated in their technology transfer activities by the
prospect of “the big hit”. They stated:
Where this has happened, it is because TTOs have been charged with concentrating too heavily
on maximizing revenues from the licensing of university-developed intellectual property, rather
than maximizing the volume of innovations brought to the marketplace.
Research Management Review, Volume 17, Issue 1
Fall/Winter 2009
Litan et al. described their research methodology as follows:
We have spent the last several years discussing the role of TTOs with multiple university leaders
and researcher-innovators.
As practitioners of technology transfer, Litan et al.’s conclusions did not comport with our experiences.
One possible source for the discrepancy is that they appear not to have included in their discussions what
is probably the most reliable source of information on what drives academic technology licensing
offices—namely the leadership of those offices. While it certainly can be argued that technology transfer
offices have a vested interest in preserving the status quo, it cannot be denied that they are a very
important source of perspective on the subject, so we decided to carry out a systematic study to ascertain
the role of various drivers of behavior in technology transfer decision-making, by surveying the
individuals who lead those offices. As will become clear in this paper, Litan et al.’s conclusions do not
comport with the findings of our research.
METHODOLOGY
We developed a survey instrument and implemented it in the SurveyMonkey system*. The questionnaire
consisted of 17 questions that were a combination of multiple-choice questions and open-ended
questions, some requesting quantitative data, some requesting qualitative information, and some
requesting opinions. The questionnaire is available in the appendix.
We sent the survey, via email, to the Association of University Technology Managers’ (AUTM) list of
the most senior individual in each member institution who is responsible for technology transfer on a full
time basis—the so-called “Director’s List”. The list is compiled from a number of sources:
¢ Self identification in AUTM’s annual membership renewal process
¢ Self identification in registration for attendance at AUTM’s annual meeting
© Identification by AUTM from the attendance list for the AUTM annual meeting
We applied to AUTM’s Statistics and Metrics Committee for access to the Director’s List, and our
request was approved.
The list AUTM supplied to us was worldwide and contained some 702 entries. We first sorted it by
country and then by institution, which yielded 425 entries ostensibly from the U.S. Inspection of the
name of the institution or the individual’s email address showed that 17 were in fact non-U.S. institutions
and one was a for-profit corporation; for 16 institutions, two individuals were identified as the most
senior licensing individual for the same campus at the same institution. In these cases, we selected one of
the two by inspecting their respective job titles. This yielded 391 useable email addresses.
We launched the survey, via email invitation, on November 27, 2007. Reminders were sent, via email, on
December 4, December 10, and December 12. Fifty-one responses were returned as “Undeliverable” or “I
have retired”. Therefore, 340 invitations to participate in the survey were presumably sent and received
by the recipient.
Research Management Review, Volume 17, Issue 1
Fall/Winter 2009
A total of 165 usable responses were returned for a 48.5% response rate. Of these, 112 of the respondents
replied to every question.
We downloaded the responses, sorted them by institution, and inspected the responses for duplicate
responses from the same institution and campus and found none. When we observed obvious errors in the
financial responses (for example, thousands instead of millions), we corrected them. In cases in which it
was not clear what the respondent meant, we called the respondent to check the figure.
In this paper, we report the responses to every question and the number of responses received for each
question. In the sections in which we looked for correlations between different types of performance and
behavior, for consistency we analyzed only the 112 complete responses.
RESULTS
Respondents
Type of Institution
The first question asked was whether the respondent was a university, hospital, research institute or
other. The results are shown in Table 2. The overwhelming majority of respondents were at universities.
Table 2. Type of Respondent
Type of Institution Number %
University 126 76.4%
Research Institute 23 13.9%
Hospital 14 8.5%
Federal Laboratory 2 1.2%
Total 165
We next asked whether the institution was publicly owned or privately owned. The results are shown in
Table 3. Publicly owned institutions made up more than 60% of the respondents.
Table 3. Ownership of Institutions
Ownership Number %
Private 63 38.2%
Public 102 61.8%
Total 165
Organization of Offices
We then asked how the TTO was organized—whether it was an operating unit of the institution or an
independent corporation such as a research foundation. The results are shown in Table 4. A total of 86%
of the offices were organized as units of the institution and only 14% were separate corporations.
Table 4. Organizational Structure of Technology Transfer Offices
Organizational Structure Number %
Research Management Review, Volume 17, Issue 1
Fall/Winter 2009
Within Institution 142 86.1%
Independent corporation 23 13.9%
Total 165
Of the 23 offices organized as independent corporations, all but one were associated with public
institutions while one was associated with a private institution. Public universities are governmental
entities and so are subject to certain contractual constraints. They frequently find it advantageous to
assign ownership of and responsibility for licensing their intellectual property to a research foundation
that is an independent 501(c)3 non-profit corporation and is not subject to the legal constraints of a
governmental entity.
Finally, we asked how the office reported within the institution—through the academic side of the
organization, i.e., ultimately to a Provost, or administratively, i.e., ultimately to a Vice President or
Executive Vice President, or to an independent Board. The results are shown in Table 5. Reporting
through the administrative side was somewhat more common, with a small proportion reporting directly
to the President/Chancellor.
Table 5. Reporting Structure of Organizations
Reporting Structure Number %
Academic 55 33.7%
Administrative 81 49.7%
Independent Board 13 8.0%
Both/President/Chancellor 9 5.5%
Other 5 3.1%
Total 163
Volume of Research Support
We asked the institutions to report the volume of their research. The total reported was $35.7 billion,
which is 78.5% of the $45.4 billion in total research support that was indicated on the 2006 AUTM
Licensing Activity Survey®. This demonstrates that our data are more representative of the totality of U.S.
academic licensing activity than the 48.5% overall response rate would indicate. We note, however, that
three federal laboratories reported to our survey—federal laboratories do not report to the AUTM
Licensing Activity Survey.
Size of Technology Transfer Offices
We asked respondents to report the total employment of their offices, divided between professional staff
and support staff. The total reported employment is shown in Table 6.
Table 6. Total Staffing of Reporting Institutions
Number of | Number
Staff Category FTEs Reporting
Professional Staff 729 153
Support Staff 587 134
Research Management Review, Volume 17, Issue 1
Fall/Winter 2009
Total 1,316
For comparison, respondents to the 2006 AUTM Licensing Activity Survey reported total employment of
1,831.7 FTEs, with support FTEs slightly exceeding professional FTEs. Respondents to our survey
therefore employed 71.8% of the employment reported to AUTM, confirming the conclusion of the
previous section that our data are more representative of total US technology transfer activity than the
overall survey response rate would indicate.
For purposes of subsequent detailed analysis, we assigned size variables to institutions based on both the
size of their total research expenditures and the basis of the total size of their technology transfer office.
The cohorts and the number in each cohort are shown in Table 7.
Table 7. Cohort Definitions and Populations (Universities Only)
Research
Expenditures Number Total Number in
Cohort ($ million) in Cohort FTEs Cohort
Very Small Up to $50 20 1-3 9
Small $51-100 23 45 33
Medium $101-250 45 6-10 42
Large $251-S00 24 10-24 36
Very Large >$500 39 >25 34
Budgeting Process
The expenses of running a technology transfer office can be broadly divided between patent costs,
normally spent externally, and personnel and other operating costs. We next asked respondents to tell us
whether they had separate patent and operating budgets or were given a combined budget, implying they
had the flexibility to spend their budget between the two categories as they saw fit. The results are shown
in Table 8. A total of 60% of institutions had separate patent and operating budgets.
Table 8. Budgeting Procedures
Budget Procedure Number %
Separate Patent and Operating Budgets 78 60%
Combined Patent and Operating Budgets 53 40%
Total 131
We next asked respondents how big their patent and operating budgets were. The totals for 114
institutions are shown in Table 9.
Table 9. Technology Transfer Budgets
Budget Category Amount %
Patent Budget $93,636,000 44.2%
Operating Budget 112,838,500 53.3%
Unspecified 5,361,000 2.5%
Research Management Review, Volume 17, Issue 1
Fall/Winter 2009
Total $211,835,500
Respondents reported spending roughly 20% more on operations—salaries, travel, services, ete.—than
on patent protection. This is the first hard data that we’ve seen of the relative balance between personnel
and legal expenditures in U.S. TTOs, though an extensive model developed by Brandt et al. based on
staffing levels reported to the AUTM Survey combined with data from a number of surveys of
technology transfer salaries (Brandt et al., 2005) came to a similar conclusion.
The 112 institutions that separately reported their operating budgets had total staffing of 925, implying an
average operating cost per staff member of $121,988 annually.
For those institutions that reported their operating and patent budgets separately, we calculated the ratio
of their patent budget to their operating budget. A ratio of 1:0 would indicate that an institution spent as
much on patent protection as on operations. We found an extremely broad spread of values, reflecting an
equally disparate spread of operating philosophies. As shown in Table 10, the range ran from a 6.4:1
ratio at one extreme’ (though this was at an institution with a relatively low overall level of activity—
$16k expenditures on patents and $3k on operations. The highest ratio at an institution with a substantial
level of activity was 3.5:1—$700k on patents and $200k on operations) to a 0.092:1 ratio (expenditure of
$60k on patents and $600k on operations) at the other extreme. The mean was 0.91:1.
Table 10. Variation in Ratio of Institutional
Patent and Operating Budgets
Statistical Measure %
Mean 91.9%
Median 60.0%
Std. Dev. 94.9%
Minimum 9.2%
Maximum 640.0%
Figure | shows the distribution of this ratio.
Research Management Review, Volume 17, Issue 1
Fall/Winter 2009
6.00 + ee
5.00
Ratio of Patent Budget to Operating Budget
Figure 1. Ratio of Patent Budget to Operating Budget by Institution
The research budgets of the 116 institutions that reported their technology transfer budgets totaled $26.5
billion, implying that these institutions spend 0.59% of their research budgets on protecting and
commercializing the results of that research.
As with the relationship between patent and operating expenditures, there is a considerable variation
between institutions in the relationship between technology transfer expenditures and total research
expenditures, from a high of 8% to a low of 0.01%. The distribution in this ratio is shown in Figure 2.
9.00%
8.00% po
7.00% +
6.00% |
5.00% |
4.00%
3.00% ~
2.00% |
‘Technology Transfer Budget as a Percentage of Research Budget
1.00% |
0.00% | a se : . " i
° 20 40 60 80 100 120
Figure 2. Technology Transfer Budget as a Percentage of Research Budget by
Institution
Research Management Review, Volume 17, Issue 1
Fall/Winter 2009
ources of Budget
Next we asked respondents how their technology transfer budgets were financed. One hundred and
twenty six institutions reported the mechanism by which their budget was financed. The number of
institutions reporting all or part of their budget coming from different sources is shown in Figure 3.
19 100% Institution [100% Licensing
Mixed Sources DOther
All Univ. PublicUniv. Private Univ. All Res. insti. PublicRes. _Private Res. Hospitals
Instit Insti
Research Management Review, Volume 17, Issue 1
Fall/Winter 2009
Figure 3. Sources of Technology Transfer Office Budget
This analysis shows that most TTOs receive their budget from a variety of sources. We found that 47%
of universities receive part of their budget from the institution and part from licensing revenue. This
reflects the reality (discussed in more detail below) that while many TTOs make money, few make
enough to cover all of their expenses without some contribution from the institution. For Research
Institutions, 57% are entirely funded by their institutions; at Hospitals, 38% are fully-funded by their
institutions.
Factors Impacting How the TTO Budget is Financed
We examined the ways in which the source of the TTO budget correlated with the total research funding
of the institution.
We found a very clear correlation between the size of a university’s research budget and how its TTO is
financed. As shown in Figure 4, at very small universities, over 60% of TTOs are entirely funded by the
institution, while none are funded entirely by licensing income. In contrast, at large and very large
universities, a significantly larger number of TTOs are funded entirely from licensing income, and
relatively few are funded entirely by the institution.
Source of TTO Budget by Size of Research Budget
(University Data Only)
0.2 @ 10%institution
1 10%Licensing
Very Small Medium Large Very
Small Large
Size based on research
budget
Figure 4. Source of TTO Budget by Size of University Research Budget
Operating Results
Research Management Review, Volume 17, Issue 1
Fall/Winter 2009
We did not ask for data on income generated by the offices from their licensing activities. However, we
did ask respondents to report the financial contribution their office made to its institution.
As discussed by Brandt et al., the profitability of an office depends on the view taken of income. There
are many claims on licensing income. As a requirement of Bayh-Dole, one portion of licensing income
must be shared with inventors. The balance is required to be spent on research and education, which in
practice means that part of the income is shared with some combination of the inventor’s laboratory,
department. and college to be spent on research, with the institution retaining only a portion to offset the
operating costs of the office. The financial contribution of the technology transfer operation to the
institution therefore depends on whether the calculation includes the portion of income that goes to the
inventors, the portion of income that is distributed and spent on research, or just the portion that is
retained to reimburse the patent expenditure and operating costs.
We therefore asked the institutions to characterize their financial performance as follows:
Category Definition
Loss Making Total expenses exceed total income
Gross Profitable Total income exceeds total expenses
Net Profitable Total income less distribution to inventors exceeds total expenses
Self-Sustaining Total income less distribution to inventors, colleges/labs, provost,
university etc. exceeds total expenses
The results are shown in Table 11. Over 50% lose money on their technology transfer operations, while
only 16% are self-sustaining, retaining more from net income after distributions to inventors and for
research than is spent on patent protection and operating costs. These results show that technology
transfer is considerably less financially beneficial to institutions than was predicted by the Brandt et al.
model, which predicted that only 42% were loss-making and that 30% of institutions were self-
sustaining.
Table 11, Financial Contribution to Institution
from Technology Transfer
Financial Contribution Number %
Loss making 68 52.3%
Gross profitable 27 20.8%
Net profitable 14 10.8%
Self sustaining 21 16.2%
Total 130
Factors Impacting Profitability
Research Management Review, Volume 17, Issue 1
Fall/Winter 2009
We found that research institute TTOs were more profitable than those at universities and hospitals, and
that private institutions were more likely to be profitable than public institutions, as shown in Figure 5.
Gross Profit
| WiLoss Making
| aver Prt
GSelt-Sustaining
Public University Private University Public Research —_—_—Private Research Hospital
Institute Institute
Figure 5. Profitability of TTOs by Institution Type
We found a direct correlation between the size of an institution’s research budget and its profitability.
The larger the research budget, the more likely the office was to be profitable, as shown in Figure 6. At
very large schools, 15% are loss-making, and 31% are self-sustaining. By contrast, at very small schools,
76% are loss-making and none are self-sustaining. The relationship between size and profitability is
almost linear—as the research budget of the institution increases, the profitability of the TTO increases.
Research Management Review, Volume 17, Issue 1
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0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0
Very Small Medium Large Very
small large
University Research Budget
Profitability at University TTOs by Research Budget Size
Loss Making
OGross Profit
@ Net Profit
O Self-Sustaining
Table 6. Profitability of University TTOs by Research University Budget
We also looked at how the profitability of TTOs correlates with the size of the office. The results are
shown in Figure 7. We found that the correlation between TTO profitability and office size closely
follows the correlation between profitability and total research budget. None of the very large
universities are operating at a loss, and none of the very small universities are self-sustaining.
Research Management Review, Volume 17, Issue 1
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Profitability at University TTOs by FTE Size
@ Loss Making
O Gross Profit
@ Net Profit
O Self-Sustaining
Very Small Medium Large Very
small large
Figure 7. Profitability of University TTOs by FTE Size
This conclusion confirms the findings of Brandt et al., who found that the greater the age, FTE count, and
research budget of a TTO, the more likely it was to be profitable. Further, they discovered that the TTOs
of only those institutions that were 15 years old and had a research budget greater than $500 million and
had a total staffing of 20 FTEs were all profitable—a very stringent set of conditions.
Reinforcing the relationship between staffing levels and profitability, a 2006 study by the Milken
Institute (DeVol et al., 2006) went so far as to calculate that an incremental investment of $1 in TTO
salaries would generate an additional $6 in license income.
We also looked at the relationship between reporting structure and profitability and found no significant
correlation.
Drivers of Technology Transfer
The next section of the survey dealt with the informal drivers of technology transfer in an institution. By
asking directors of TTOs for their rankings of the possible drivers of behavior, we hoped gain an
understanding of how TTOs prioritize the forces shaping their behavior in their daily decision-making.
First, we asked the respondents what drives the TTO. Respondents were asked to rank six factors in order
of priority from 1 to 6:
Revenue maximization
Faculty service
Research results translation
Industrial sponsored research income
Research Management Review, Volume 17, Issue 1
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e Risk management
e Other
Table 12 shows how many institutions ranked each factor as the most important driver of their office.
Faculty service was ranked first most often, followed by translating research results. Maximizing revenue
was ranked most important by only 11.5% of institutions.
We did not include “Economic Development” as an option, which anecdotally is reported to be a
significant driving force at publicly owned institutions. This may explain the relatively high number of
“Other” responses.
Table 12. Top-Ranked Drivers of Technology Transfer
Number of Institutions
Driving Factor Ranking Factor First %
Faculty Service 51 39.2%
Translating Research Results 45 34.6%
Revenue Maximization 15 11.5%
Other 15 11.5%
Research Support 4 3.1%
Risk Management 0 0.0%
Total 130
Factors Impacting Drivers of Technology Transfer
As shown in Table 13, the drivers were broadly similar for both universities and research institutions,
with research results translation being the most important factor at research institutions while faculty
service was most important at universities. At hospitals, research results translation was again the most
important factor, while financial factors—revenue maximization and research support—were relatively
more important than they were for universities and research institutions.
Table 13. Top-Ranked Driver of Technology Transfer
by Type of Institution
Type of Institution Top-Ranked Driver
Public Univ. Faculty Service
Private Univ. Faculty Service
Public Res. Inst. Research Results Translation
Private Res. Inst. Faculty Service
Hospital Research Results Translation/Other
As shown in Figure 8, as the size of the university increases, the top driver changes from Faculty Service
(over 60% in small and very small universities) to Research Result Translation (35% and 54%,
respectively, at large and very large universities). The choice of Revenue Maximization as the top driver
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increases linearly from very small to large schools, but is not a factor at any very large schools.
Industrially Sponsored Research Income was listed as the top driver at so few schools that we regarded it
as not significant.
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0
Top Ranked Driver of Behavior by University Research Budget
@ Research results
translation
O Faculty service
@ Revenue maximization
O Industrial sponsored
research income
Very Small Medium Large Very
small
@ Risk management
large © Other
Figure 8. Top Ranked Driver of Behavior by University Research Budget
As shown in Figure 9, when we compared public and private universities, we found that Faculty Service
is the top-ranked driver at a much higher rate at private universities than at public universities (56% vs.
41%, respectively), and Research Result Translation is chosen by a greater number of public universities
than private universities (34% vs. 26%). Revenue Maximi:
tion was listed at the number one driver at
14% of public universities versus only 7% of private universities.
Research Management Review, Volume 17, Issue 1
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Top-Ranked Driver of Behavior at Public vs. Private
Universities
@ Research results translation
O Faculty service
@ Revenue maximization
O industrial sponsored research
income
@ Risk management
Other
Public University Private University
Figure 9. Top-Ranked Driver of Behavior at Public vs. Private Universities
As shown in Figure 10, when we looked at the top-ranked drivers of TTO behavior we found a steady
decrease in the importance of faculty service to research results translation as total research expenditures
increase.
mRosearch results transiation
DFaculty service
Very small Small Medium Large Very large
Figure 10. Effect of Research Budget Size on Top-Ranked Driver of Behavior
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at Public Universities
We looked at whether the top driver of TTO behavior correlated with the organizational structure—i.e.,
do the priorities of the TTO change if the TTO reports to the administrative side of the university versus
reporting to the academic side, and found no significant difference.
Finally, we examined whether having revenue maximization as the top driver of technology transfer
translated into enhanced profitability. The results are shown in Table 14. There is no clear correlation
between the two.
The results of these analyses show that an industry standard seems to have been adopted throughout the
profession. Translating research results and providing a service to the faculty are clearly the primary
drivers of TTO behavior, whether the TTO is large or small, private or public, or whether it is making
money or losing money.
Table 14. Top Drivers of TTO Behavior Based on Profitability (All Institutions)
Research Revenue Industrial
Result Faculty Max- Sponsored Risk
Profitability No. Trans. Service — imization Research Management Other
Loss-Making 58 31% 45% 12% 9% 0% ™%
Gross Profit 24 33% 38% 8% 0% 0% 13%
Net Profit 12 33% 42% 25% 0% 0% 8%
Self-Sustaining 18 33% 39% 11% 0% 0% 17%
Total 112 32% 42% 13% 4% 0% 10%
Technology Transfer Office Mission
We next asked institutions if the technology transfer office has a formal mission statement. The results
are shown in Table 15. A surprising number of offices do not have a formal mission statement.
Table 15. Technology Transfer Offices with a Formal
Mission Statement
Formal Mission Statement Number %
Yes 75 58.6%
No 53 41.4%
Total 128
We next asked those offices that have a formal mission statement to provide us with information on their
mission statement. While only 75 institutions answered yes to this question, 80 submitted a copy of their
mission statement.
The following are typical of the mission statements we received:
The XXXX Office of Technology Transfer promotes and supports the research enterprise at the
University by creating relationships with the private sector to develop, protect, transfer and
commercialize research results for the public benefit.
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As a service provider, assist XXXX, its researchers, and its community partners with the
development and promotion of biomedical innovations.
¢ “Support the educational, research, and healthcare mission of the University by fostering
creativity and innovation.
e Initiate and sustain cooperation and collaboration between the University and business and
industry.
e Actas the University's intellectual property management and technology marketing arm.
e Advance healthcare-related economic development for our state and the nation.
¢ Support economic development through technology licensing.”
It is the mission of the TTO to encourage broad practical application of System research for
public benefit; to encourage and assist those associated with the System in the protection,
licensing and commercialization of their discoveries; to ensure the equitable distribution of
royalties and other monetary benefits resulting from the commercial application of intellectual
property; and to see that commercialization activities benefit the research, education and
outreach missions of the System into the future.
We searched all of the mission statements for keywords such as “value”, “income”, “revenue”, “financial
return” and “maximize” that would speak to a focus on financial return. We found mission statements
such as:
Promoting the transfer of XXXX’s life science & medical technologies for public use and
benefit, while generating income to support campus research and education.
Our mission is to help facilitate scientific research at the Institute, promote transfer of Institute
basic research discoveries to the marketplace for the public benefit, and generate revenue for
further research.
¢ To facilitate the movement of Institute's inventions from research to application.
e To create value in the inventions by protecting them with patents and ensuring Institute’s
ownership rights.
¢ To commercialize Institute's intellectual property in accordance with Institute’s mission and
external granting agency guidelines (NIH, NSF, HHMI).
e To generate revenue for Institute, its inventors and its continued research through
commercial licensing.
¢ To facilitate development of the local Biotechnology Industry and economy. (emphasis
added in each case)
The term financial return did not occur in any of the mission statements, and the words maximum and
maximize each occurred only once in each of two mission statements that were the only ones that seemed
to establish maximizing financial value and return as the mission of the office.
To maximize the value of XXXX’s intellectual assets through the creation of novel and effective
models for commercializing technology.
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The essential mission of the Office of Technology Transfer is twofold:
(e)) to promote the timely transfer of commercially valuable knowledge and inventions
developed in the University to the businesses most capable of reducing them to practice
and benefiting the economy of XXXX and the nation, and
(2) to return maximum value for such commercialization to the inventor/s and to the
University in support of its continuing research enterprise, in a manner which upholds
sound ethical, legal, and academic standards. The value of technology licensing for the
University includes its benefits in providing incentive to faculty for research and
invention as well as the dollars received for financing continuing University research
activity. (emphasis added in each case)
Incentive Compensation
The final section of questions concerned incentive compensation. We first asked whether any personnel
in the office receive incentive compensation. The results are shown in Table 16. Clearly only a minority
of personnel receive bonuses.
Table 16. Offices in Which Some Personnel Receive a Bonus
Do Some Personnel Receive a Bonus Number %
Yes 22 17.2%
No 109 85.2%
Total 131
Next we asked how many personnel in the office receive bonuses and compared the answer with the
reported number of staff. The results are shown in Table 17. Clearly, in the relatively small number of
offices that offer bonuses, bonuses tend to be offered broadly within the office.
Table 17. Availability of Bonuses within the Office
Number Receiving Bonus Number %
All 9 40.9%
More than the Professional Staff 3 13.6%
All Professional Staff 2 9.1%
Fewer than All Professional Staff 2 9.1%
One 6 27.3%
Total 22
Next we asked how the bonuses were calculated. First we asked whether they were calculated based on
office performance, individual performance, or a combination of the two. The results are shown in Table
18. Clearly, the most prevalent practice is to incentivize a combination of total office performance and
individual performance.
Table 18. Basis for Computation of Bonuses
* One respondent answered “NO” to question
about having an office bonus scheme, but then
gave details of a bonus scheme—that it was
available to all professional staff and that it was
22 based on overall office performance.
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Calculation Basis Number %
Individual performance 2 8.7%
Office performance 4 174%
Combination of office + individual 17 73.9%
Total 23*
Finally, we asked for information on the bases on which bonuses are calculated. From a list of five
specific factors, we asked whether each was taken into account in calculating bonuses and, in addition,
allowed respondents to identify one of more “other” factors. Respondents could identify as many factors
as were relevant to their experience.
To analyze the data, we first reviewed what was entered in the “other” column, and entered the count for
the number of specific factors identified by respondents.
Twenty one of the 22 respondents who reported that they had an incentive compensation plan identified
the factors taken into account in computing incentive compensation. The 21 respondents reported 81
factors that were taken into account. A statistical analysis of the responses is shown in Table 19. Both the
mean and the median Incentive Compensation Plans took into account four factors, though several only
took into account one factor and one plan took into account eight factors.
Table 18. Number of Factors
Taken into Account in Calculating
Incentive Compensation
Measure Value
Mean 3.90
Median 4.00
Std. Dev. 2.57
Min 1.00
Max 8.00
As shown in Table 20, the most common factor taken into account in computing Incentive Compensation
was “Other”, followed by Total Income and Transactions Completed, followed by Disclosures Received.
Table 19. Factors Taken into Account in Awarding
Incentive Compensation
Factor Number %
Other 18 22.2%
Total income 14 17.3%
Transactions completed 14 17.3%
Disclosures received 10 12.3%
Operating surplus 9 11.1%
Faculty satisfaction 9 11.1%
Start-ups formed 7 8.6%
Total 81
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The “Other” category included the following, several of which were cited by multiple respondents:
Beneficial products and services introduced to society
Community service
Exclusive licenses
Faculty education activities
New revenue
Overall university financial performance
Performance against specific targets
Regional economic impact
Only two of these factors—Total Income and Operating Surplus—are financial return-oriented and
account for 28.4% of the factors cited, while the remaining 10 are oriented toward broader measures of
technology transfer performance.
ANALYSIS AND DISCUSSION
Our methodology was designed to make four independent determinations of the behavior of technology
transfer in an institution through four independent sets of questions:
¢ How is the office financed?
¢ What drives the office—i.e., what behavior is the office actually demonstrating?
e¢ What are the office’s incentives based on—i.e., what behavior does the institution really
want and is prepared to pay extra for?
e What is the official mission of the office—i.e., what behavior has the institution told the
office it wants from it?
First, looking at the sources of the TTOs’ operating budget, we found that 20.3% of offices are required
to generate between 50% and 100% of their operating budgets from their license income. These
institutions clearly have an incentive to maximize the income they generate simply in order to stay in
business.
Next, looking at the actual behavior the offices displayed, we found that the most important drivers of
technology transfer were faculty service and translation of research results. Only 11.5% of offices stated
that maximizing revenue was the most important driver of technology transfer.
Third, looking at the behavior the institution really wanted and was prepared to pay extra for to obtain,
we found that fewer than 20% of institutions provided incentive compensation to their TTOs; among
those that did, only 28% of the factors taken into account in determining incentive compensation focused
on financial return, with the remainder focused on broader, non-financial measures of performance. This
means that only 5.6% of offices were incented based on financial performance.
Finally, the most visible way to make income important is to put it in the TTO’s mission statement.
While a surprisingly high percentage of TTOs had no formal mission statement, only 2 out of 80
institutions that did have a formal mission statement—2.5%—mentioned maximizing income or revenue
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in their mission statement. This proportion falls to 1.6% of the 128 institutions that gave either a “yes” or
“no” answer to the question on whether they had mission statements.
The results of these four separate determinations are summarized in Table 21:
Table 20. Summary of Estimates of Extent to which Behavior is Driven by
Income
Extent Driven by
Area of Investigation Income
Operating Budget 20.30%
Drivers 11.50%
Incentive Compensation 5.60%
Mission Statement 2.30%
CONCLUSION
The results of these four independent determinations were consistent in demonstrating that financial
return is not the major factor in technology transfer organization and behavior, as is often posited.
There is a very clear trend in our results and an obvious conclusion to be drawn from them, namely that
the more visible the factor we used to determine TTO behavior, the lower the frequency with which we
found income maximization to be the most important factor.
e The most indirect way of encouraging revenue maximization is to make the operating budget of
the TTO dependent on the income it generates. This had the highest incidence—20.3% of TTOs
were required to generate half or more of their operating budget from the income they generate.
e Also subtle were the priorities that the TTOs reported as driving their activities; here only 11.5%
of TTOs reported that revenue maximization was their most important driver.
e Including revenue maximization as part of an incentive compensation program means that an
institution has made a formal, senior-level determination that it wants the TTO to maximize
revenue, and is a much more overt measure. We found revenue maximization accounted for only
5.6% of incentive compensation.
e Finally, the most visible and public statement of an institution’s desire for its TTO to maximize
revenue is to include revenue maximization in the TTO’s mission statement. Only 2.3% of the
mission statements we were sent included revenue maximization as one of the TTO’s missions.
We therefore conclude that, depending on the visibility of the measure of what drives the TTO, from
2.3% to 20.3% of technology transfer activities are driven by financial considerations, with most activity
being driven by broader objectives such as translation of research results and service to the faculty.
Which of these four very different figures represents the “best” measure? The average of the four figures
is 9.9%, which is reasonably close to the 11.5% of TTOs that reported revenue maximization as the
primary driver of their activities. If someone wanted to summarize our findings in a Twitter, we would
suggest, “Only 10% of technology transfer activity in the U.S. is driven by revenue maximization”—or
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perhaps its corollary, “80% of echnology transfer activity in the U.S. is driven by social rather than
revenue considerations.”
We therefore respectfully disagree with the conclusions reached by Litan et al. discussed in detail earlier,
in which they concluded that:
...TTOs have been charged with concentrating too heavily on maximizing revenues from the
licensing of university-developed intellectual property, rather than maximizing the volume of
innovations brought to the marketplace (Litan et al., 2007, n.p.).
In our research we found the direct opposite—that translating the results of research and servicing faculty
are the primary drivers of technology transfer offices.
We believe these results are not surprising in light of the way technology transfer is organized in the U.S.
Fewer than 15% of TTOs are organized as independent corporations. An independent corporation can
develop a culture that is quite distinct from that of the parent institution, whereas if the TTO is an
integral part of the institution, it will inevitably share its culture. Outside the U.S., particularly in the UK
and Australia, independent corporations tend to be the preferred TTO model. The extreme example of an
independent corporation is Imperial Innovations, PLC, the technology transfer arm of Imperial College,
London, which is an independent corporation that is publicly traded on the Alternative Investment
Market of the London Stock Exchange’. Clearly, Imperial Innovations has a fiduciary responsibility to its
shareholders to maximize its profits, and it can no longer hew to the university’s charitable mission.
Finally, we confirmed an earlier study that found that for over half of institutions, technology transfer is
actually a cost to the institution rather than a source of income and that only 16% of institutions retain
enough of their income to reimburse all the costs of operating their TTOs, after sharing their income with
various stakeholders, such as inventors, labs, and the university.
We therefore predict that institutions which established their TTOs in the expectation of a “big hit” are
likely to be disappointed; however, institutions that establish their offices with a broad set of goals will
likely see their objectives realized.
We should conclude with a caveat. The above findings and conclusions should not be interpreted as
implying that TTOs do not care about the financial terms of the license transactions they negotiate and
will “give” the technology away. Far from it. Technology transfer offices have a strong sense of fairness
and will fight hard to ensure that their institution shares fairly in the fruits of success if their technology
is successful in the marketplace. Rather, our conclusions mean that income is not the primary motivator
of offices; technologies with smaller market potential will receive as much attention as those that serve
large markets; if there is a single, credible potential licensee interested in a technology, then the office
will negotiate exclusively with that company rather than seeking additional licensees to create a
competitive bidding situation; junior faculty will receive as much attention as senior faculty; and non-
financial, academic and social considerations will be taken into account in negotiating deals.
Public Policy Implications
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Although it was not one of the objectives of our research, our study has important public policy
implications for the role of academic research in innovation ecosystems, both in the U.S. and globally.
The Bayh-Dole Act was intended to break down the Chinese walls that had grown up between academic
and corporate research and to integrate academic innovation into the U.S.’s innovation ecosystem. While
it is beyond the scope of this article to discuss the economic impact of Bayh-Dole, studies have shown
that it has succeeded admirably in this regard (Bayh, Allen, & Bremer, 2009; Jensen et al., 2009;
Roessner et al., 2009). However, our study leads to the surprising conclusion that Bayh-Dole has turned
out to be an unfunded mandate on U.S. academic institutions.
Bayh-Dole provided no direct funding for the technology transfer activity it was about to trigger. It was
anticipated that the costs of technology transfer would be included in each institution’s indirect cost base
and that, subsequently, licensing income would rise to cover the costs of the activity. Two factors
changed this expectation:
1. The administrative component of indirect costs was capped at 26% in the early 1990s—IDC
no longer covers the complete costs of carrying out research. A recent study found that U.S.
patent costs are only included in the IDC base at three U.S. academic institutions.
2. Equally, licensing income has not grown fast enough to cover the cost of the technology
transfer function at most institutions, for several reasons (Stevens, 2003).
Licensing income grew slowly for several reasons. First, it took time for academic institutions to
establish TTOs. The AUTM Annual Licensing Survey shows that the first wave of technology transfer
offices were created fairly evenly over a thirteen-year period centered on 1990 (running from 1983 to
1996), not immediately after the passage of Bayh-Dole in 1980. TTOs continued to be created after 1996,
albeit at a much slower rate, though there was another spike of start-ups in 1999 and 2000. Next, once
TTOs were established, it took time to recruit and train staff, for a culture of technology transfer to
develop on campuses, and for a portfolio of licensable inventions to develop. Then, because academic
inventions are generally very embryonic and leading (bleeding?) edge, it generally takes from one to four
years to find a licensee to make a commitment to develop a technology. And finally, since the majority of
the most valuable academic inventions have been drugs, they have had to go through the 10- to 15-year
clinical testing and FDA approval process.
The next issue is that few licenses generate substantial income. AUTM data show that only around 1% of
licenses generate more than $1 million in income in any given year”. While this may sound substantial, a
typical TTO would distribute around $750,000 of the $1 million to inventors and for research and only
retain around $250,000 to cover TTO patenting and operating costs. The data in Table 1 shows that the
incidence of the truly “big hits” is even more unevenly distributed and is primarily concentrated in a
relatively small number of institutions that have created important drugs and vaccines.
Finally, only a relatively small amount of license income is used to offset the costs of technology
transfer. At most institutions, 60-75% of income is distributed to the inventors to incentivize them to
participate in the technology transfer process, and to laboratories and colleges to be spent on further
research.
This issue also has implications outside the U.S. Over the past decade, many countries, initially in
Europe and now in developing countries, have adopted the institutional ownership model of academic
invention management pioneered by Bayh-Dole. Many have recognized this financial dilemma and have
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provided funding to kick-start the process. However, most have made the same assumption that the U.S.
Senate did, and have provided funding for only relatively short periods of time—typically five years.
Normally the TTOs are still well short of self-sustainability when the funding runs out and difficult
decisions then have to be made.
We conclude, therefore, that new funding models for technology transfer are needed, both domestically
and outside the U.S.
AUTHORS’ NOTE
We thank the Association of University Technology Managers for providing us with access to its
Directors List, and Janine Anderson, Boston University, for her meticulous proof-reading of the
manuscript.
END NOTES
1. P.L. 96-517, Patent and Trademark Act Amendments of 1980; see, for instance,
http://www.autm.net/aboutTT/aboutTT_bayhDoleAct.cfm
2. http://Avww.autm.net/about/dsp.licensing_surveys.cfm
3. http://www. paulcapitalhealthcare.com/newsroonyfundnews/012308.htm
4. http:/Avww.kauffman.org/items.cfm?itemID=786, accessed 12/22/07.
5. http:/Avww.surveymonkey.com/
6. http://www.autm.net/about/dsp.pubDetail2.cfm?pid=41
7. One institution reported a patent budget of $600k and an operating budget of only $37k despite
reporting two professional and one support FTE. It appears that they misunderstood the question and
reported only their “All other” budget and not their total operating budget, and we did not include these
data.
8. Imperial College owns 51% of the company’s stock.
9. For instance, the 2008 U.S. Annual Licensing Activity Survey found that of 15,498 licenses that were
generating income, including 7,917 licenses that were generating running royalties (i.e., had advanced to
a marketed product), only 192 licenses generated more than $1 million in income.
LITERATURE CITED
Bayh, B., Allen, J., & Bremer, H. (2009). Universities, inventors and the Bayh-Dole Act. Life Sciences,
Law and Industry Report, 24(3), 1-5.
Bok, D. (2003). Universities in the marketplace : The commercialization of higher education. Princeton,
NJ: Princeton University Press.
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Brandt, K. D., Stevenson, E. J., Anderson, J. B., Ives, C. L., Pratt, M. J., & Stevens, A. J. (2005). Do
most universities lose money on their technology transfer activities? Annual Meeting, Association of
University Technology Managers, Phoenix, AZ.
Coleman, M. S. (2005). Address before the Annual Meeting, Association of University Technology
Managers, Phoenix, AZ.
DeVol, R., Bedroussian, A., Babayan, A., Frye, M., Murphy, D., Philipson, T. J., Wallace, L., Wong, P.,
& Yeo, B. (2006). Mind to market: A global analysis of university biotechnology transfer and
commercialization. Santa Barbara, CA: Milken Institute (available at:
http://www.milkeninstitute.org/pdf/mind2mrkt_2006.pdf
Jensen, J., Wyller, K., London, E. R., Chatterjee, S. K., Murray, F. E., Rohrbaugh, M. L., & Stevens, A.
J. (2007). The role of public sector research in the discovery of new drugs. Annual Meeting, Association
of University Technology Managers, San Francisco, CA.
Jensen, J., Wyller, K., London, E. R., Chatterjee, S. K., Murray, F. E., Rohrbaugh, M. L., & Stevens, A.
J. (2009). The contribution of public sector research to the discovery of new drugs. Paper presented at
BIO Technology Transfer Symposium, San Francisco, CA.
Krimsky, S. (2003). Science in the private interest: Has the lure of profits corrupted biomedical
research? Lanham, MD: Rowman & Littlefield.
Litan, R. E., Mitchell, L., & Reedy, E. J. (2007). Commercializing university innovations: Alternative
approaches. Paper online via the Social Science Research Network, and on the Jssues in Science and
Technology web page: http://www. issues.org/23.4/litan.html.
Roessner, D., Bond, J., Okubo, S., & Planting, M. (2009). The economic impact of licensed
commercialized inventions originating in university research, 1996-2007. Report to the Biotechnology
Industry Organization, Washington, DC.
Shane, S. A. (2004). Academic entrepreneurship: University spinoffs and wealth creation. New York:
Edward Elgar.
Stevens, A. (2003). 20 years of academic licensing — Royalty income and economic impact. Journal of
the Licensing Executives Society International (Les Nouvelles), 38, 133-140.
Thursby, J. G., & Thursby, M. C. (2003). Patterns of research and licensing activity of science and
engineering faculty. Atlanta, GA: Georgia Institute of Technology.
Washburn, J. (2005). University, Inc.—The corporate corruption of American higher education. New
York: Basic Books.
29
Research Management Review,
Appendix
Questionnaire
Volume 17, Issue 1
Fall/Winter 2009
1. Section 1. General Information about your office:
‘hls Se 2 small survey on how Offices of Fechnology Transfer are organized, mixsioned, Hinanoad and
evaluated,
‘Thls survey wit only take $ minutes of your time te complete. AR responce received will be: treated ae
<onfiventiat ingormetion. You have our assurance tat we wit not disclose any information in miaewer shat
allows it to be refered to amy individual institation. We will onty publish composite date ané any stratification
Iweckets for purposes of data analysis will be Drasd encugts bo tnciude af lewet. theee knstititiors.
‘Thank you,
1, Your institution is az
Ureuneaiby oe Cina
onetat
Aveerch Ineitate
ee (stan spwsityd
2. Your institution is:
"Ditty wmv
3. What were the Total Research Expenditures (in million dollars) of your
institution in the fiscal year 2007 (including overhead or indirect costs (IDC)?
5. How many Ful Time Employees (FTE) are there in your office?
erdecsines toning lt cs
port stat It
6. Does the Office of Technology Transfer report up through:
CO} the nendente we atc atta tan, timate te 9 Proven)
CS she neiutentvn 0 9th nates Ca lucy ts #9 tractive in Fmt
30
Research Management Review,
Volume 17, Issue 1
Fall/Winter 2009
2. Section U. Budget
‘ens sun hss ata from ve tem yane 2007 oe shis seeon.
1, The Office of Technology Transfer is financed by: (Please enter a percentage
%e)
Inatuution'e epeceiing vudoat
towne mec racers
A two Suns (ag, Income rates by an tnsapandinch
‘cerpanata weticy)
Shae inom soarens
2. Boes your office have SEPERATE Patent and Operating budgets?
Ow
yu
3. To the nearest thousand dollars ($), what were your:
MET Patent Pxpneae (owen anpancen aha reimbursement)
‘ottcn Gowrating Eoewnaa Um, pwcneMOW! ane ter
spencer
‘Tote! Hapansan (ei of he snore
4. Which category does your office fall into? (Total expenses as calculated in
Question 3)
{Tota Licensing Income in Sane than Tota! Repenwen Nee Lowe?
‘otal Licanang Invnmne cents Total Bxpeunen (rors Brel?
*) Met Lecemeing income (i.0., S90 income inious frosty personal where) mxcemce Total Expacnen (fat Prottt)
ine yose teva eatnio « share of Semcasng teeane for gael puoycune, dhe ramanning tomnaing imconen eth
~ encase Tote Expenuas (lly Sait Sopperngh
31
Research Management Review, Volume 17, Issue 1
1. What drives the Office of Technology Transfer: (Please rank the following
choices from 1 to 6, with 1 being the MOST IMPORTANT.)
Renan maxtoteation
ecatty secon
Snsanods nessa asann
Indeteit eperaaved sunwacch wnccome
U8 manegernent
‘Detar (nce spit in Was Miesion Stttamesr bas at the wr
a che setts)
2. Does the Office of Technology Transfer have a formal Mission Statement?
ve
¢
O-
3. If yes, what is the Mission Statement? (Please cut and paste the statement
into the box below.)
Fall/Winter 2009
32
Research Management Review, Volume 17, Issue 1
1. Do any personnel in the Office of Technology Transfer receive incentive
compensation (banus}?
lok
5
2. How many people in the office are entitled to receive incentive compensation?
3. Incentive compensation is based on:
4. What is the incentive compensation based on? (Please choose all that apply.)
£7) total income
parang marion
“ sranamctions compat
ocinovree wcened
Bary companies termed
Preatty seveteeton
‘tear isernn temtyd
"Tile & the end oF the suzvey. Thank you very much for your participation
Pompe 4
33
Fall/Winter 2009
Research Management Review, Volume 17, Issue 1
Fall/Winter 2009
ABOUT THE AUTHORS
Irene Abrams is Executive Director of the Office of Technology Licensing at Brandeis University.
Before joining Brandeis, she was a senior technology licensing officer at the Massachusetts Institute of
Technology (MIT) and the Whitehead Institute. She is a founder of T3, an organization of small
technology-transfer offices in New England. She also serves as president of the Massachusetts
Association of Technology Transfer Offices. She holds a bachelor’s degree from the University of
Pennsylvania, a master’s degree from Johns Hopkins University, and was a doctoral student at MIT.
Grace Leung is a Business Development Associate in the Office of Technology Development at Harvard
University. Prior to joining Harvard, she was an intern at the Office of Technology Licensing at Brandeis
University. She holds a Bachelor of Science and a Master of Philosophy in Biology from the Chinese
University of Hong Kong, and a Doctor of Philosophy in Molecular Biology and Microbiology from the
Tufts University Sackler School of Graduate Biomedical Sciences.
Ashley Stevens is Special Assistant to the Vice President of Research at Boston University and was
previously Executive Director, Technology Transfer in the Office of Technology Development. He is
also Senior Research Associate in the Institute for Technology Entrepreneurship and Commercialization
in Boston University’s School of Management, where he teaches two graduate-level, inter-disciplinary
courses on technology commercialization. Before joining Boston University, he was Director of the
Office of Technology Transfer at the Dana-Farber Cancer Institute, a teaching affiliate of the Harvard
Medical School. Prior to entering the technology transfer profession, Dr. Stevens worked in the
biotechnology industry for nearly ten years and founded two companies. He started his career with the
Procter & Gamble Company. He is President of the Association of University Technology Managers
(AUTM) and was previously its Vice President, Annual Meeting and Surveys. He was the recipient of
the Bayh-Dole Award at AUTM’s 2007 Annual Meeting. He is also active in the Licensing Executives
Society, the Massachusetts Association of Technology Transfer Offices, which he co-founded, and the
Massachusetts Biotechnology Council. Dr. Stevens holds a Bachelor of Arts in Natural Sciences, a
Master of Arts and a Doctor of Philosophy in Physical Chemistry from Oxford University. He is a
Certified Licensing Professional.
34
From: Wertz, Jennifer (NIH/OD) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=1E6CB9797CEF40F1B40E777AFE3795D7-WERTZJ]
Sent: 10/4/2018 9:32:39 PM
To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]
Subject: Re: Voice Mail (24 seconds)
Attachments: 978-1-68083-401-7.pdf
Here you go. Looks like you have to first log in and the click the link to the book in the email.
Let me know if this doesn't work and I'll try again when I get home. Haven't tried doing attachments from the
new email phone app yet.
Have a good trip.
Jenn
——- Original Message --------
From: "Rohrbaugh, Mark (NIH/OD) [E]" <«
Date: Thu, Oct 4, 2018, 5:20 PM
To: "Wertz, Jennifer (NIH/OD) [E]" <
Subject: Voice Mail (24 seconds)
Hi Jenn it's Mark I had logged into the now publishers dot com website.
And I'm showing up it's showing logged and with your user name but I don't see where you can download -- anything so
-- if you could give me a call.
Thanks bye.
Preview provid
You received a voice message from Rohrbaugh, Mark (NIH/OD) [E] (Work) at 3944354485.
Caller-Id: 3014354485
Job Title: Director
Company: NIH
Work: 381. 4485
Mobile: ai
Email:
Measuring Science,
Technology, and Innovation:
A Review
Measuring Science, Technology,
and Innovation: A Review
Bronwyn H. Hall
University of California at Berkeley,
USA and University of Maastricht,
The Netherlands;
bhhall@econ.berkeley.edu
Adam B. Jaffe
Brandeis University, USA;
ajaffe@brandeis.edu
Now
the essence of knowledge
Boston Delft
Annals of Science and Technology Policy
Published, sold and distributed by:
now Publishers Inc,
PO Box 1024
Hanover, MA 02339
United States
‘Tel, -+1-781-985-4510
www.nowpublishers.com
sales@nowpublishers.com
Outside North America:
now Publishers Inc.
PO Box 179
2600 AD Delft
‘The Netherlands
‘Tel. +31-6-51115274
‘The preferred citation for this publication is
B.H. Hall and A.B. Jaffe. Measuring Science, Technology, and Innovation: A Review.
Annals of Science and Technology Policy, vol. 2, no. 1, pp. 1-74, 2018.
ISBN: 978-1-68083-401-7
© 2018 B.H. Hall and A.B. Jaffe
All rights reserved. No part of this publication may be reproduced, stored in a retrieval system,
‘or transmitted in any form or by any means, mechanical, photocopying, recording or otherwi
without prior written permission of the publisher
Photocopying. In the USA: This journal is registered at the Copyright Clearance Center, Inc., 222
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Annals of Science and Technology Policy
Volume 2, Issue 1, 2018
Editorial Board
Editor-in-Chief
Albert N. Link
University of North Carolina at Greensboro
United States
Editors
ch
Indiana University
David Audret
William Bonvillian
MIT
Be Bozeman
na State University
Kaye Husbands Fealing
Georgia Institute of Technology
John Hardin
North Carolina Board of Science and Technology
Mariagrazia Squi
OECD
Wolfgang Polt
Joanneum Research Institute
Nicholas Vonortas
The George Washington University
Editorial Scope
Topics
Annals of Science and Technology Policy publishes survey and tutorial articles
in the following topics:
Literature reviews of technology and innovation policies
Historical ¢
studies of technology development and implementation
Institutional histories of technology- and innovation-based organizations
Analyses of policies attendant: to technology development and adoption
and diffusion
Studies documenting the adoption and diffusion of technologies and
subsequent consequences
Studies of public and private research partnerships (cross sectional,
over time, or case based)
Assessments and evaluations of specific technology and innovation
policies
Analyses of ecosystems associated with the technology and/or
innovation development
Cross observational (e.g., cross-agency or cross-country) comparisons of
technology and innovation policies
Information for Librarians
Annals of Science and Technology Policy, 2018, Volume 2, 4 issues. ISSN
paper version 2475-1820. ISSN online version 2475-1812. Also available
as a combined paper and online subscription.
Contents
What is an indicator?
The relationship between indicators and a framework for analysis
OBST i ether 39 atacarg aE TSH heh, By WED Ge 1 TLS
A model of the STI system
Limitations of growth accounting
Overview of existing U.S. indicators
International context
Innovation surveys
Other innovation indicator efforts
STI indicators for STI policy
Issues and Gaps in existing U. S. indicators
Innovation measures
35
ORNS ISSUES! x.y ¢. eed, a Sicaetanieh Nee ee oink we me eadeearee Med he
7 Conclusion
References
Author Biographies
60
68
73
Measuring Science, Technology,
and Innovation: A Review
Bronwyn H. Hall! and Adam B. Jaffe?
1 University of California at Berkeley, USA and University of
Maastricht, The Netherlands; bhhall@econ.berkeley.edu
2 Brandeis University, USA; ajaffe@brandeis.edu
ABSTRACT
‘The measurement of scientific, technological, and innovative
activities (STI) in the economy is an increasing challenge
ul agencies around the world. In thi
t. We discuss the concept
faced by statisti view,
we survey the current state of the ¢
of indicators, their quality and use, and present a schematic
model of the STI system that can help us identify gaps in
commonly in use. We then review the
the set of indicato
developments in STI measurement that have taken place
in the rest of the world, particularly the widespread use
of innovation surveys. The monograph concludes with a
sues in the U.S.,
discussion of the measurement gaps and
which we identify as innovation (especially in the service
sector), non-R&D investment related to innovation, data
timeliness, data linkages, measurement related to public
policy goals, and the sources of capital for innovation.
Bronwyn H. Hall and Adam B. Jaffe (2018), “Measuring Science, Technology, and
Innovation: A Review”, Annals of Science and ‘Technology Policy: Vol. 2, No. 1, pp
1-74, DOT: 10.1561/110.00000005.
1
What is an indicator?
An “indicator” is a set of facts or observations that tells us some-
thing meaningful about the underlying phenomenon of interest, in
this case science, technology and innovation (henceforth STI). In or-
der to evaluate whether a particular set of facts is a good indicator,
or to determine whether there are indicators we should have that
we do not, we need to consider in some detail what makes a partic-
ular set of facts meaningful. In this section we address the impor-
tant dimensions that affect the meaning and usefulness of an indica-
tor.
set of data. The word “data” is a
plural of the Latin datum meaning “given.” We frequently think of data
The foundation of an indicator
in the form of numbers, but conceptually data can be either quantitative
or qualitative. Either way, formal analysis of data is predicated on the
idea that the data are, indeed, given, meaning that they are generated
by the world itself rather than created by the people who want to use
them. In reality, what we call “data” in most contexts are numbers or
qualitative observations that are usually collected by human beings,
and the nature of this collection process combines with the “givens” of
the world to determine what are recorded as “data.”
The relationship between indicators and a framework for
For many purposes — particularly their use by policy makers and
other “lay” people concerned about science, technology and innovation
— presentation of data without further processing does not constitute
a meaningful indicator. All of the indicators published by NSF are
constructed in some way from underlying data. So any recommendation
about an indicator is, in a sense, a compound recommendation: (1) what
d
data should be collected, and (2) how should those data be summar’
1
in a published indicator or indicators
The relationship between indicators and a framework
for analysis of STI
In order to determine whether an indicator is meaningful, we need to
assess both the data that are used, and the manner in which those data
are summarized. Carrying out this as ment requires specific
the underlying concept we are trying to understand, and the relationship
between this concept and the process that generates the data. For
example, we tabulate how many academic degrees of various kinds are
granted each year. We don’t really care about degrees per se, but we
re in some way about the knowledge and skills of the population, and
ca
we believe that the number of degrees granted and the fields in which
nted is unulation
Are gy: ; in some way informative about the a
of knowledge and skills. We measure income in various ways. For some
purposes, we might care about income itself, but more often we are using
income as an indicator of well-being or happiness or success. Sometimes
the proxy nature of our measurements is explicit; in other cases it is
implicit. But either way, we cannot assess how meaningful an indicator
is without thinking about its relationship to the concept or concepts
that we really care about.
But where does the s
atement “the number of deg)
s granted is in
some way informative about the accumulation of knowledge and skill”
' Date
without creation of summary indicators) by s¢
collect
ed by the government are also used in disaggregated form (i.e.
ial tists and others interested
in studying the underlying phenomena. We return below to the importance of the
inter-relationship between the collection of data in support of indicators, and the
use of data for research.
4 What is an indicator?
come from? And why do we think that the population’s accumulation of
Jmowledge and skill is itself something we care about? The determination
of both what aspects of the real world matter, and what measurements
are illuminating with respect to these aspects will be based on some kind
of framework, either explicit or implicit. A framework is an abstract
representation of the world, typically focusing on one or a small set of
aspects (e.g. science, technology and innovation). Such a framework can
ty of ways
be constructed and described in a varie : economists like to
use symbols and equations; anthropologists tend to use words; systems
engineers frequently use diagrams. Whatever the mode of presentation,
the framework is designed to capture the essence of the underlying
complex reality. Even if such a framework is not fully articulated, it
will underlie the choice of data collected and the interpretation placed
. In this report, we make the framework we
on the resulting indicator:
are using explicit, because we believe that leads to greater clarity.
Having a framework for analysis is also important for the question of
how data and indicators can inform public and private decision-makin|
In order to use data to inform decisions, we again need an understanding
of what those data tell us about the workings of the STI system. Either
explicitly or implicitly, we have some kind of framework in which those
data relate to the instruments or the goals of our decisions. Again, we
believe that being explicit about the framework leads to greate:
in understanding how the data or indicators relate to the goals and
clarity
instruments of policy.
Note that the relationship between any framework for analysis and.
tive one. We need some kind of framework to organize
data is an ite
ideas and to know what data we should be looking for, and to support
interpretations of the data that we see. At the same time, social scientists
and others will use the data to test various models, by studying the
extent to which the predictions of their models are borne out in the data.
This process may suggest changes to the framework used and also to the
data that is needed for analysis. We return below to the implications of
this two-way relationship between the data and the model.
In Section 2, we summarize the framework for analysis of the STI
system that is most widely used by economists. In this framework, for
Uses of STI indicators 5
example, the level of knowledge and skills of the population is important
for several reasons: it affects the amount of goods and services that
s the rate at which new
can be produced per capita, and it also affe
knowledge is produced, which affects the improvement over time in the
amount of goods and services that can be produced. In Section 3, we take
the next step, and consider how the specific data currently collected by
the U.
to the important concepts within the framework. Section 4 expands this
. government, and indicators constructed from those data, relate
discussion by reviewing data collected and indicators published by other
countries and international organizations. Section 5 then turns to the
issues of policy, and draws explicit connections between important policy
questions and indicators, using the framework of Section 2. Section 6
then builds on these discussions to highlight gaps and issues with the
existing indicators. Section 7 provides concluding comments.
Uses of STI indicators
In addition to understanding the data underlying an indicator, how
those data were processed, and the relationship of the data and its
processing to a framework for analysis of the STI system, evaluating
indicators also requires an understanding of the purposes for which they
are used.
Performance assessment and benchmarking
Some indicators serve as performance measures that give an assessment
of whether the STI system or some component thereof is doing better
or worse over time, and better or worse than some comparison group
(e.g. other countries). For this purpose, the indicator may stand for
system that is intrinsically valued (e.
some aspect of the . income), or
it may stand for an aspect of the system that, within the framework,
is understood to have important impacts on aspects that are valued.
For example, past research has suggested that, all else equal, a greater
intensity of investment in new knowledge will lead to higher rates of
productivity growth and income growth. For this reason, one might focus
on the R&D/GDP ratio over time or across countries
a» benchmark
6 What is an indicator?
of innovative activity. But in doing so, one should always keep in mind
the role of knowledge investment in the framework, and the relationship
between the framework concept of knowledge investment, and the R&D
data that are actually collected. In this example, it is clear that spending
on R&D may not capture all of the investments that are directed towards
creating new knowledge (and may capture some investment that is not
thus directed). In addition, the share of innovation-related investment
captured by an R&D measure may be changing over time so that the
measure is potentially misleading taken on its own. The framework
also makes clear that there is no particular level for this ratio (such
as 3%) that is optimal. Finally, even though the relationship between
R&D investment and productivity growth is well established, it is still
true that R&D investment is an indicator of innovative activity, not an
indicator of innovation, which is the concept we think is more closely
associated with the growth outcomes of interest.
Informing public policy decisions
An important function of STI indicators is to provide an informed basis
for public policy decisions. But of course policy is not intended to affect
the indicators, it is intended to affect the underlying concepts of interest.
So to determine if a suite of indicators is well-suited to inform public
policy, one needs to identify the goals of public policy, and to use the
framework for analysis of STI to understand how those goals relate to
data that can be collected. We discuss these issues in Section 5.
Informing private sector decision-making
Firms and individuals in the for-profit sector also use STI indicators
to make business decisions, and not-for-profit organizations (e.g. uni-
versities) use them to make decisions in pursuit of their missions. It is
unclear to what extent these parties needs and desires are different from
those of policymakers, and, if they do differ significantly, to what extent
these distinct needs are considered in the decisions made by government
statistical agencies about the STI indicators system.
Issues of data collection and indicator construction 7
Facilitating social science research
As noted above, social scientists use data to test the implications of
models, and thereby refine the models. Hence their interest in the
indicators endeavor is more in the collection and availability of data
than in indicators per se. But because model testing and validation
is so important, we will comment in the concluding section on how
the needs of social scientists might be considered in the context of
recommendations about indicators.
Issues of data collection and indicator construction
As noted above, though formal statistical theory treats data as “given,”
y process by which the data are created
in reality the potentially mess
and compiled is sometimes important in evaluating indicators. In this
section we identify a few basic issues.
Data dimensions
Data collected to construct indicators may span time, space and institu-
tional categories. Construction of summaries to be reported as indicators
can then be aggregated along one or more of these dimensions, depend-
ing on the purpose of the indicators. Reporting of indicator values in
a time serie
is frequently of interest; this raises issues of consisten
of interpretation of the summary values based on data collected at
different points in time. Comparisons across different geographic areas,
or across different categories of institutions (e.g. small firms versus
large firms), are also of interest. When comparing data from the same
point in time, but different institutions or geographic areas, there is an
issue of comparability that is analogous to the consistency issue when
it is often useful to be
comparing over time. For analytical purpose:
able to construct a panel, in which the indicator of interest varies across
2
both time and another dimension such as geography or institution type.
The need for comparability can come into conflict with the need to
?For micro-data analyses, it is often valuable to have access to longitudinal data,
in which data from the same individuals or institutions is collected at multiple points
in time.
8 What is an indicator?
redesign surveys and data collection methods in response to a changing
landscape, especially in the case of indicators describing innovation.
How the data were generated
Some data collected for use in STI indicators are generated by companies
or other organizations in the normal course of their business for their
own internal use; some are also generated by these organizations for
other external reporting requirements (e.g. financial reporting required
by Generally Accepted Accounting Practices). Other data are generated
by organizations specifically in response to government requests tied to
STI data collection. The advantage of using data otherwise generated in
the course of business is that it may be less burdensome for the entities
involved. Also, the intrinsic importance of the data elements to the
organizations may lead to greater care and consistency in construction,
compared to data that are generated only because NSF asks for them.
On the other hand, precisely because the data are created for other
purposes, they may be less ideally suited to the intended purpose than
data that can be specified with their intended STI indicator use in
mind.
How the data are collected
For data that are generated for other purposes, there is also a potential
distinction between data that are collected by explicit survey requests
to the entities that created the data, and data that can be collected
passively, i.e. without the active ¢
ssistance of the generating entities.
Examples of passive collection include mining of data from reports filed
by companies with agencies such as the SEC or IRS, and “scraping” of
data from websites. The advantage of passive collection is minimization
of burden on the generating entities. In some cases, there may also be an
advantage inherent in the absence of an opportunity for the entities that
generate the data to manipulate strategically what is reported. On the
other hand, when passively collecting data generated for other purposes,
it may be difficult to understand fully what the data really mean and
difficult to control the sampling frame to ensure representativen:
2S.
Data quality 9
Public versus private data collection
When we speak of indicators, we tend to think of data collected and
published by the government. But social science researchers can and
do collect data themselves. What is the appropriate mix of government
and non-government collection of data and publication of indicators?
Data that are of wide potential use have an important public-good
attribute. But researchers studying STI can apply for public funding
of their research, thus solving the public good aspect of the problem
without having the government be the party that collects and pub-
lishes the data and indicators. The government does have particular
advantages as data collector, where the data in question are related
to other data that the government collects for statutory purposes (e.g.
census data), and/or the data are considered proprietary and therefore
unlikely to be provided by private agents without government mandate.
But, by definition, this mandatory data collection principle can only
be applied to a limited number of data elements. Recognizing the scope
for individual investigators to collect a variety of information beyond
what i
collected by the government greatly increases the potential
scope of indicators available to public and private decision-makers. This
true with re
is particular! spect to data that can be collected pas-
sively, as discussed above, because in such a case the requirement of
AS
mandatory compliance that the government can bring to its surveys
is not necessary. Thus, in considering the possibilities that may be
created for additional indicators by passive data colle
tion, we should
not assume that these data have to be collected and published by
the government. There is considerable scope for individual researchers,
probably with public research funding, to collect and publish such
data.
Data quality
Before moving on to the framework for anal, ators within the
STI s
they affect the quality of data. This section draws heavily on Griliches
(1986), which can be consulted for more detail.
system, we pause briefly to review measurement issues and how
10 What is an indicator?
Griliches categorizes issues of data quality as falling into three
categories: extent, reliability and validity. Extent refers to the scale and
scope of the data: for how many years has it been collected, how many
different data items are collected, and how broad is the coverage in
terms of regions or types of institutions. With respect to extent, more
is better, in a fairly straightforward way.
Reliability refers to the inherent reproducibility of the data collection
process itself, In effect, it asks, if the data were collected on different
oceasions or in different places, and nothing real about the world were
different in the two times or places, how close would the different data
be to each other? They won't typically be the same, because each
ty
of the signal-to-noise ratio, i.e., the fraction of the variance in the data
that i: stematic rather than random.
Validity refers to the extent to which the data are generated and col-
measurement includes random sampling error. Reliabi a measure
lected in a manner that makes them correspond closely to the underlying
into consid-
concept that we care about. Griliches subdivides validi
erations of relevance and representativeness. Relevance is, in essence,
the question of the extent to which what we are measuring is closely
related to what we care about. Representativeness arises in any context
in which we collect only a data sample, i.e. we do not collect data from
all relevant individuals or units. It refers to the extent to which the
different kinds of units had the same probability of contributing to the
data (or if the probabilities differed, they did so in a systematic way
that we can account for).
To illustrate these concepts, consider the NSF industrial R&D
survey. It is very extensive, because it goes back many decades, and
covers all firms and all parts of the country. It is reliable, in part
because it is so extensive, and in part because the definitions and
procedures are well established and understood. But how valid it is
really is a question of what underlying STI concept you wish to use it
to measure. Its relevance i
potentially questionable, because it looks
only at formal R&D activities, which may not be the right thing to look
at if what we care about is overall knowledge investment. In the past
(prior to redesigns in 1992 and 1995) its representativeness may have
Data quality 11
been questionable, because the sampling frames failed to adequately
sample small and medium-sized firms and firms in the service sector.>
These observations don’t mean the data are useless; they simply make
the point that the validity of a set of data can only be judged in the
context of the framework for analysis of STI and the role to be played
by those data within the framework.
As noted above, there is variation in the ex
ent to which the potential
gap between the measured item and the model concept is explicitly
acknowledged. Virtually everyone who uses patent statistics to measure
rate of invention or innovation notes explicitly that patents are only
for the underlying concept. But the issue of proxies is really
more one of degree than of kind: for virtually every indicator we use
we must acknowledge some degree of potential distance between the
measurement and the concept it
as a mild epithet that applie
tands for. Rather than viewing “prox
to some indicators but not others, it makes
more sense to consider, in all cases, the extent to which a particular
tor might deviate from the underlying cone
It is also worthwhile to consider how the choice of indicators and
indie spt for which it stands.
As noted
method of data collection affects their reliability and validity
above, there may be significant benefits in terms of government resources
and burden on private parties to expanding the use of data that is
passively collected through methods such as web scraping, instead of
government surveys. With statistically designed surveys, however, we
have both a high degree of reliability, and, perhaps more important, a
clear understanding of the level of reliability and possible sources of
unreliability. With passive methods, it may be much harder to assess
reliability, precisely because the relationship between the captured data
and the universe of underlying activity is not known.
tors has to be sensitive to a
Finally, collection of data for indic:
variety of different ways in which the collection itself may affect behavior
and thereby change the data. The “Hawthorne effect,” whereby the
mere act of observation may cause people to behave differently, has
been understood for some time. In this neutral form, it
3 See the NSF website for information on the changes in sampling during the
1990s. http://www.nsf.gov/statistics/nsf02312/seetb.htm
12 What is an indicator?
assumed that one can predict the nature or direction of the change in
behavior that results from observation. A more complex and dangerous
problem arises from the combination of data that are imperfect proxies
for an underlying behavior, with the use of those data to evaluate and
reward the people who generate the data.
For example, it is entirely reasonable to use numbers of published
papers
We know that the relationship between the proxy and the underlying
and citations as a proxy for the generation of new knowledge.
phenomenon is imperfect, but as long as the relationship is stable across
tor. Even if there are
differences in the relationship in different times or different cont: it
may still be a useful indicator if we know what those differences are,
or can use statistical methods incorporating additional information to
both time and context, it can be useful indic
correct for them. But if we increase our reliance on such data for the
purpose of evaluating and rewarding individuals or organizations, they
will then have an incentive to generate more papers relative to the rate
at which they are generating new knowledge. This can easily generate
changes o
time in the relationship between the data and the concept
of interest, and the extent of these changes may vary across institutional
contexts. These effects then make the proxy indicator less informative
about the underlying phenomenon of interest.
There is no total solution to this problem, because, as noted above,
virtually all indicators are to some degree proxies that may diverge from
the underlying concept of interest. But some ma
kind of endogenous distortion than others. It is also possible that this
consideration should weigh in favor of passive data collection rather
y be less subject to this
than surveys, to the extent that people are more likely to respond to
the possible incentives created by data collection if they themselves are
active participants in its collection.
2
A model of the STI system
In this section we outline a stylized model of the way in which sci-
ence, technology, and innovation contribute to economic welfare. A
science, technology, and innovation (STI) system consists of a number
of components linked by the knowledge and resources that flow among
them. These components obviously include governments, government
research laboratories and extension services, the intellectual property
(IP) system, higher education and research institutions, venture capital,
and industrial research laboratories. Less obviously, they also include
individual actors in any arena that are engaged in improving the effi-
ciency of their production, introducing new ideas and new products, or
even making the effort to adopt a new technology or method of organi-
ion of these institutions
zation. When the system works well, the intera
and individuals produces welfare-enhancing economic growth via the
introduction of new and improved processes, products, and services.
For a comparative study of the operation of different national inno-
vation systems around the world, see Nelson (1993). In that volume, the
authors emphasize the importance of interaction among the components
of such a system in producing good outcomes. To take a simple example,
high quality educational and research institutions are less effective in
13
14 A model of the STI system
generating economic growth within a country if firms are not capable
of making use of either the graduates or the research output they gen-
erate, or thi
research jobs is preferable to working for firms. Another example would
be the failure or inability of potential entrepreneurs to put good ideas
into practice due to lack of a venture capital system or other form of
» graduates find that employment in secure government
financing.
The task at hand here is to consider the production of indicators
that might help in monitoring such a system and designing policies that
enhance its functioning if nec
ary. Because the innovation system is
embedded in the entire economy and touches almost all of it and because
it is inherently an intertemporal system, the overall framework used to
structure anal,
is is generally an economic growth model. This model
expr 2 output as a function of ordinary input:
such as capital and labor, and adds to the
es aggregate econom
» inputs stocks of intangible
knowledge assets, which are assumed to improve the production of
output above and beyond the level produced by the other inputs. The
use of stocks is
intended to capture the idea that knowledge generated
in one period is useful in many subsequent periods. These knowledge
assets are used to incr
ase the amount of goods and services that can
be produced by any given amount of human labor and other inputs.
They also may be used to produce de such as health, clean
environment and national security, which are largely unpriced and may
ables
not be adequately included in aggregate output, something we will
return to later in our discussion. In addition, to some extent the stock
of knowledge may also produce unpriced undesirables. For an example,
see Rogoff (2017) on the food manufacturing and marketing indust
where there may have been a negative impact of techn
that industry on obesity and health, that outweighs the advantages of
1
1 change in
increased efficiency and lower cost of production.
A stylized version of such a growth model can be written like this:
Y~ C°Lo KY
1 A related literature questions the implicit assumption that more innovation is
always better. E.g., David (2012) and Soete (2012).
15
or in growth rate form as:
gy = ogc + gu + 79K +e
In this formulation, Y is output, C is ordinary physical capital, L
is labor input, K is a measure of knowledge assets, the gs are the
corresponding growth rates, and e is any output growth that cannot be
d
for over 50 years to describe and account for the sources of economic
growth (Abramovitz, 1956; Solow, 1957; Jorgenson and Griliches, 1967).
s been t
» inputs. In various forms, this model he
explained by thes
However, it is important to note that use of this model requires estimates
of the weights a, 8, etc. For growth accounting purposes, it is assumed.
that the capital inputs are supplied competitively. The shares can
then be estimated as the nominal shares of nominal income received
by the various factors, which creates some difficulties detailed below
when knowledge capital is included separately. In contrast, most: micro-
econometric productivity work estimates the weights a, 8 rather than
computing them from income shares, an approach that requires weaker
assumptions on the nature of competition. The result is that growth
accounting measures the contribution of the knowledge assets using input
costs, whereas the econometric approach measures their contribution
12
using output producec
Recently the U.S. system of national accounts has begun to incorpo-
rate one aspect of knowledge stock, the knowledge produced by R&D
investment, both public and private, into a so-called R&D “satellite
account (Carson, 1994). This is feasible because R&D data have been
collected over a long time period (from 1953) and therefore stocks can
be constructed. Fraumeni and Okubo (2005) use the resulting system
of national accounts (specifically the National Income and Product
Accounts or NIPA) to estimate the contribution of R&D to economic
growth over a forty-year period 1961-2000. They measure the income
ues arise due to the lack of firm-level price deflators
and the contribution of innovation spending to quality change and market power and
therefore pricing. These issues always are there in growth accounting, but become
more important when evaluating the role of innovative activity in production, because
two of the goals of innovative activity by firms are quality improvement and the
creation of market power via product differentiation.
2 In practice a number of i
16 A model of the STI system
share of R&D by a:
rate, and perform sensitivity anal:
suming both a rate of return and a depreciation
ysis by varying these rates. They
found that returns to R&D capital accounted for 7 to 11 percent of real
GDP growth, with a range of 4 to 15 percent under their most extreme
assumptions. In addition, treating R&D as an investment raises the
national savings rate by two percentage points from 19 to 21 percent
and has a small positive effect on the measurement of GDP growth
because the creation of R&D capital is added to GDP, and R&D has
grown faster over time than GDP.
Using the growth accounting framework, indicators can be used
to measure both the level of important stocks in this system and the
rate of important flows. Both stocks and flows can be measured at
different points in time, and the exercise performed at different levels of
aggregation, that is, for different kinds of organizations such as business
or government, different regions, or different industrial s 's. Possible
investment flows that might be considered as indicators include the
following:
e The resources that are being expended toward the goal of new
knowledge creation, which is largely R&D, but may include other
; tr:
necring and marketing expense ¢
expenditures such
ining in new processes or design, engi-
oeiated with new products.
e The resources expended on new capital equipment that is as
)-
ciated with the introduction of new processes and methods of
organizing production (broadly defined to include the production
of services and nonprofit/government outputs
© The resources expended in educating scientists and engineers.
The rate at which advanced degrees in S&E are received.
e The rate at which new knowledge is being generated, such as
measures of patents applied for or publications.
e The rate at which knowledge is being transferred between or
among different regions or organizations, sometimes measured by
citations.
Limitations of growth accounting Af
© The rate at which new products or new methods are being incor-
porated into production of goods and services.
Most of these flows can be transformed into stocks, with varying rates
of depreciation, and incorporated into the growth accounting framework
described earlier. In section 4 of this report, we describe how the
currently available indicators might fit into this system.
Limitations of growth accounting
Growth accounting is a useful schematic for organizing one’s thoughts
about the sources of economic growth, but it has a number of limita-
tions, especially in the analysis of intangible knowledge and innovation
investments. We highlight three: 1) the assumption of normal rates of
return; 2) the omission of unpriced output; and 3) that fact it obscures
tem, by focusing only on the
input expenditures and the final output in the form of economic growth.
the underlying functioning of the STI
Normal rates of return
The share weights in the growth accounting framework are computed by
multiplying an estimate of the annual return to a knowledge asset times
a measure of the knowledge stock and dividing by total nominal output.
Assuming a stream of investments Ry, Ry-1,... and using a declining
balance formula with deprecation rate 5 to compute the knowledge
stock, we have the following equation for the stock:
Kp = (1 — 5:) Kti+ Re
‘The share weight for its contribution to growth is the following:
(re + Ot) Ke
ii re
where pY is nominal output and r, is the net rate of return to the
knowledge investment. These equations depend heavily on the assumed
depreciation rate 5 that may vary over time, and on the assumption
of a normal rate of return. In the absence of markets for knowledge or
innovation assets, we have relatively little information on their values
18 A model of the STI system
and what information we do have suggests that both depreciation and
return vary greatly over time (Hall, 2005). In addition, there is the
obvious fact that returns to innovation at the industry or economy-wide
level, unlike returns to ordinary tangible assets, are not tied down by
the discipline of the market, because of the existence of knowledge
spillovers.
Unpriced outputs
A second limitation of growth accounting is related to the fundamental
question of what we should be measuring as output: GDP or some
other concept such as Net Economic Welfare (NEW) or Gross National
Happiness (GNH). In the case of innovation, the problem of output
measurement centers on the lack of good price data for a set of innovation
outputs that include improvements in health from investment in the
healthcare sector, national defer
, and improvements in environmental
quality.
With respect to healthcare, the US Bureau of Economic Analysis is
currently engaged in a project to develop a satellite account for health
spending that involves the following tasks: 1) creating a set of health
ics that is common to BEA and the Center for Medi-
expenditure stati
care and Medicaid Services (CMS), and 2) producing a comprehensive
set of health care sector accounts for health care income, expenditure,
and product.? In turn, this involves developing medical care price and
real output measures that break out the delivery of health care from
increases in the price of that care, rather than simply capture output
of the sector via input spending. To the extent that this project is
successful, it should improve our ability to track the contribution of
spending on health-related innovation to improvements in healthcare.
Popp et al. (2010) review the economic research on the impact of
innovation in the environmental area, including energy. Much of this
research focuses on measurable output, such as pollution levels, or on the
inducement of innovative and R&D activity in this area via legislative
standards. Another growing area of research is dynamic modeling of
5 For further information about this effort, see http://www.bea.gov/national/
healthcare Hite_account.htm (2012).
Limitations of growth accounting 19
the implications of R&D directed at climate change for the economy
(e.g., Acemoglu et al., 2012; David et al., 2011). None of this work
provides much guidance for translating the intermediate outputs such
as reductions in pollution or reduced risk from global warming into
measures of economic welfare. But it does suggest that in some areas
of innovation, the measurement of dir
+t effects like the reduction in
effluents, air and water quality, and so forth, may be relevant.
Evaluating the contribution of innovation to national defense and
some kinds of environmental improvement or avoidance of environmental
damage is considerably more challenging. ‘This is an area where tracking
spending seems the best we can do. In the case of national defense, a
long history of analysis in this area points to important spillovers to non-
military applications from defense-related R&D investment (Mowery,
2010). Tracking these effects would involve tracking military R&D
spending by area, which is already done to some extent. Addi
ional data
that might be useful would be entry, growth, and non-military sales
shares for firms that contract with the Defense Department to develop
new technologies, products, and services. Some evidence of this kinds
exists for small firms via evaluation of the SBIR set-asides (Wessner,
2009).
Inside the STI system
The growth model identifies the relevant inputs and outputs, but leaves
the mechanisms that connect them unspecified. In the words of Rosen-
berg (1982), it is a “black box.” The inputs are expenditures to increase
knowledge stocks and related capital equipment, as well as the quality
and education of the labor for
». The outputs are knowledge stocks in
the subsequent period and output growth. But a number of intermediate
inputs and outputs are clearly worth tracking. First, there is the human
pital embodied in the labor force, which is partly the creation of
the education and job training systems in the economy. Second, the
knowledge stocks created by innovation investments are used to produce
new and improved products and processes, which in turn lead to the
growth of output. Third, the various actors engaged in innovation and
knowledge creation interact in ways that add to output and we would
20 A model of the STI system
like to measure this also, in order to understand the mechanisms that
encourage such interaction.
Thus ideally we would like to have indicators for inputs, intermedi-
ates, and outputs. To put it another way, we are interested in indicators
of innovative activity, innovation, and the impact of innovation on
economic welfare. As a general rule, inputs are easier to measure than
outputs, mostly because some ent
to aggregate them (using dollar expenditure). On the other hand, the
is paying for them so we have a way
intermediate and final outputs of innovation are often either untraded,
or is qualitative, so it is more difficult to measure and to aggregate.
‘That is one reason why we sometimes rely on productivity anal
which allows the use of national income measures such as GDP, or sales
in the case of firms, adjusting these measures for the level of other
inputs
A final observation is that once one goes within the innovation
system (unpacks the black box), it quickly becomes clear that there
is feedbe
from later stages to earlier. That is, the so-called “linear
model” of innovation is not quite an accurate picture. Various authors,
led by Rosenberg (1982), have emphasized this feature of the process.4
Nevertheless, from a policy perspective, it is natural to think of the
model in this way, be 2 it is primarily the inputs (in the form
of spending on innovation, basic re:
us
search, higher education, and the
like) that are subject to policy intervention. In addition, it cannot
be emphasized enough that innovative output is subject to great deal
or planners, The
indicators are of interest,
of uncertainty that is beyond the control of pol
implication is that although output or succe
they will not turn out to be much of a guide for detailed planning.
* See also Kline and Rosenberg (1986). Balconi et al, (2010) present a thoughtful
defense of the linear model. Among other things, they point out that in many cases
basic science has served as an essential basis for subsequent innovations.
3
Overview of existing U.S. indicators
The state of the existing indicators for the U.S. economy can be seen in
the biannual volume published by NSF, entitled Science and Engineering
Indicators. Table 3.1 summarizes the indicators available in the latest
tion, dated 2012, and covering data through
volume of this publi
2010 in most
of innovation measures, many of the numbers in it are drawn from
es. Although the table suggests an apparent wealth
administrative records collected for another purpose, and may not be
ideal for the measurement of innovative activity. Nevertheless, these
statistics provide a very useful starting point. In addition, many of
the measures we do have, such as various types of R&D spending and
patents granted, are specialized towards the manufacturing sector and
technological innovation. Thus they provide valuable, but incomplete
coverage of the full range of innovative activities. Other measures, such
as value added in various sectors, are bottom line measures influenced
by many other factors in addition to innovative acti
21
Overview of existing U.S. indicators
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Overview of existing U.S. indicators 27
e inputs,
Figure 3.1 presents a schematic summary of how resour
knowledge outputs, and ultimate impacts flow in the economy, providing
a framework for assessing which aspects of the system are captured well
by existing indicators and which are captured les:
gles represent the main actors in the knowledge economy-government,
the education sector including public research organi:
industries, and the finance sector. The red hexagrams represent the
well. The blue rectan-
zations, various
two main classes of research and innovation collaboration, between
industry and university, and between public (governmental) and pri-
vate organizations. The yellow ovals are the two intangible assets of
the knowledge economy, which are difficult to measure: the knowledge
base (largely codified and/or not embodied in individuals) and human
sapital (largely tacit and/or embodied in individuals). The green arrows
represent flows of resources (funding) from one sector to another, and
the dotted arrows represent intermediate knowledge outputs that flow
between and among the sectors. The heavy dark arrow at the bottom
indicates that the for-profit sector, using both internally and exter-
nally generated knowledge, generates commercial innovation, which
then manifested in output growth, productivity improvement, and
enhancement of individual welfare.
is
The Figure is designed to capture, in a stylized way, the important
investment mechanisms and the important impact pathway:
of the
endogenous growth model described in the previous section. We see,
for example, that both the education sector and the industry sector
contribute to the creation of new knowledge and new human capital,
and these knowledge stocks in turn feed back into both the education
and industry sectors to foster cumulative knowledge growth. Within the
industry sector, we have shown two (of many) industries, to represent
that knowledge spillovers flow between industries, as well as between
firms in a given industry (illustrated within the right-hand industry in
the diagram). Also within industries lie R&D labs, which are largely
funded from within industry, but also receive public funds. These labs
are a source (but not the only source) of knowledge creation within the
industrial sectors. Finall
, the gov
the knowledge creation sectors.
rmment is a major funder of all of
28
Overview of existing U.S. indicators
i
. i
(3) Knowledge (4) Human {
— capital i
(7) Industry
Funding
<> Knowledge
‘===> Commercial Innovation
TFP; output
growth; welfare
Figure 3.1: Schematic Overview of the STI System.
The last two columns of Table 3.1 show the connections between the
STI Indicators currently published by NSF and the stocks and flows in
's that appear in each polygon in Figure 3.1
Figure 3.1, using the numbe
to make the connections So, for example, in the first row of the table,
an indicator related to elementary and secondary test scores is labeled
“2 4,” indicating that it corresponds to the arrow connecting the
rectangle (2) to the oval (4) in Figure 3.1.
Perusal of Table 3.1 and Figure 3.1 together indicates that our exist-
ing indicators are quite complete in their coverage of the resource flows
that support the generation of new knowledge, containing considerable
information about the magnitude and distribution of those flows. There
Overview of existing U.S. indicators 29
are also multiple indicators that correspond to knowledge and human
capital outputs, although these measures are universally proxies that
are related to the underlying concepts with substantial measurement
error (e.g., degrees
papers as a measure of new scientific knowledge; patents as a measure
sure for the human capital of graduates;
as a mee
of new technical knowledge). The measures of innovation (as opposed
to innovative activitie:
are much less complete, and arguably more
“distant” from the underlying concepts. For example, the errors of both
inclusion and under-inclusion in using new trademark registrations
spond-
for innovation are probably even greater than the cori
as a pre
ing errors in using patents as a proxy for new inventions. And a similar
observation applies to using high-tech value added as an indicator for
increased output that can be attributed to innovation.
We will return to a d
the existing NSF Indicators, after a discu
analogous data collection and publication efforts in other countries.
cussion of the potential issues and gaps in
ion in the next section of
4
International context
Almost every developed and mid-level developing country in the world
has been concerned to some extent with the problem of measuring
innovation. Broadly speaking, most have arrived at some combination
of R&D spending, tertiary education, patenting activities, publication
and success in exporting and
activities, research funding availabili
growth. In addition, many countries have made use of the innovation
surveys pioneered in Europe to assess the innovative activities of their
own firms. See Table 4.1 for a list of the countries that have fielded one
or more innovation surveys.
‘Two aspects of these international efforts are important for the U.S.
innovation indicator enterprise. First, as a latecomer in some areas
cond,
of measurement, we can learn from the experience of others. Se
the fact that many countries are constructing “innovation scoreboards”
means that there is a demand for international comparability of at
least some of these measures, in order to facilitate various kinds of
benchmarking. However, exact comparability is difficult to achieve
due to differences in the ways questions are interpreted, the structure
of industrial firms, and differences in the cultural and institutional
30
International context 31
Region
‘Table 4.1: Innovation Survey
Countries Website
BU27
Austria, Belgium, Bulgaria, http://www.proinno-europe.eu/metrics
Cyprus, Czech Republic,
Denmark, Estonia, Finland,
France, Germany, Greece,
Hungary, Ireland, Italy,
Latvia, Lithuania,
Luxembourg Malta,
Netherlands, Poland,
Portugal, Romania,
Slovenia, Slovakia, Spain,
Sweden, UK
Rest of
Europe
Norway, Switzerland http://www.ssb.no/innov_en/
http://www.kof.ethz.ch/en/surveys/
structural-surveys/
Latin
America
Argentina, Brazil, Chile, http://www.r
Colombia, Cuba, Ecuador,
Mexico, Panama, Pern,
‘Trinidad and Tobago,
Uruguay
Asia Japan, Korea, Malaysia http://www.nistep.go.jp/en
http://www. kistep. :/en/c3/sub2.jsp
Pacific Australia, New Zealand
Other Canada, South Africa http://www.statcan.ge.ca/concepts
ex-eng-htm
Both DIW and NESTA (discussed below) have introduced several
measures that might be used to capture some of the cultural differences
across countries. These measures include some that are already col-
lected by the NSF, such as attitudes to the development of technology
despite its potential risks, and evidence on the public’s interest in new
inventions and technologies. Additional measures that might be useful
are those for buyer sophistication with respect to innovation, the level
of computer and internet skills, social capital and trust. A particularly
salient measure for the development of entrepreneurship is the measure
of the fear of failure, which is frequently identified as an important
32 International context
reason for lower entrepreneurship rates in Europe, but might also be
useful for comparing regions within the United States.
Table 4.2 below gives an idea of the innovation indicators that are
being measured by the European Union. Some of them reflect partic-
ularities of the European institutional setting. A couple of examples:
1) The focus on measuring climate change mitigation innovation is due
to a strong policy stance of the EU with respect to green technology.'
2) The age restriction on doctoral graduates is probably because it
is extremely unusual in Europe for anyone to go back to school for a
doctoral degree at older ages, unlike the situation in the U.S. However,
in general similar indicators can be or already have been constructed
for the United States, with the notable exception of those based on the
innovation survey questions, at least to date. In the following subsection
s what has been learned from others’ experience with these
surveys, and what the U.S. is doing in this area.
! Bg, see the Europe 2020 agenda for growth. http://ec.europa.eu/europe2020/
index_en.htm
International context 33
‘Table 4.2: European Union Innovation Indicators.
Input or Broad = Available
output area Indicator in US?
New doctorate grads per 1000 pop New PhDs
Human par
Input : aged 25-34
cnput capital
indicators Share of pop aged 30-34 having Yes
(human completed tertiary educations
capital) - -
Share of youth aged 20-24 having Yes?
attained at least upper secondary
level education
Intl. scientific co-publications per___In principle
Research million pop.
system
Scientific publications among the top _In principle
10% most cited publications
worldwide as % of total scientific
publications of the country
Non-BU doctorate students per Non-US
million pop.
ae Public R&D spending as share of Yes
inance cpp
Input VG (early stage, expansion and ?
indicators replacement) as share of GDP
industry
(industry) Business R&D spending as a share of Yes
investment GDP
Non-R&D innovation spending as a No
share of turnover
Linages and SMEs innovating in-house as a share Not at present
Entrepreneur- of SMEs
ship Innovative SMEs collaborating with No
others as a share of SMEs
Public-private co-publications per _In principle
million pop.
34 International context
Table 4.2: continued
Input or Broad i. Available
output area Indicator in US?
F PCT patent applications per billion Yes
itp? Knowledge GDP
indicators assets PCT patent applications related to In principle
societal challenges per billion GDP
(climate change mitigation; health)
Community trademarks per billion US trademarks
GDP
Community designs per billion GDP US trademarks
SMEs (>10 employees) introducing Not at present
Innovators product or process innovations as
share of SMBs
Output SMEs (>10 employees) introducing — Not at. present
indicators marketing or organizational
innovations as share of SMEs
High-growth enterprises as share of —??
all enterprises (???)
Employment in knowledge-intensive Yes
: ___ activities (manufacturing & services)
Economic as a share of total employment
effects a
Medium and high-tech Yes
manufacturing exports as a share of
total product exports
Knowledge-intensive services exports possibly
as a share of total service exports
Sales of new to market and new to
firm innovations as a share of
turnover
Not at present
License and patent revenues from
abroad as a share of GDP
Source: European Union (2012, 2012) and authors additions.
Yes
Innovation surveys 35
Innovation surveys
The challenge of measuring innovation broadly has been met at least
partially during the past 20 or so years by the introduction of direct
surveys of business firms in many countries. Although earlier pioneering
surveys of various kinds exist, this activity really took off with the
publication of the first edition of the Oslo Manual in 1992 (third edition,
Tanaka et al., 2005), which had guidelines for the definition of various
kinds of innovation and for the collection of innovation-related data.
For example, several non-R&D kinds of innovative expenditure were
identified in the manual: the later phases of development and testing
that are not included in R&D, capital expenditures related to the
introduction of new processes, marketing expenditures related to new
products, certain kinds of employee training, expenditures on design
and technical specific
tions, ete.
The Oslo Manual defines innovation as follows:
“An innovation is the implementation of a new or signif-
icantly improved product (good or service), or process, a
new marketing method, or a new organisational method
in busines workplace organisation or external
practices.
2
relations.”
In spite of the apparent clarity of this definition, measuring in-
novation in a form that is useful for statistical analysis has proved
challenging. The central problem is that no two innovations are alike.
Some innovations (e. g., the invention of the telephone or perhaps the
telegraph) create a whole new market sector whereas others are useful
but trivial, and there is a wide range in between. In general we can
say that smaller innovations are more numerous than game-changing
ones. As an illustration of this phenomenon, consider the data of Acs
and Audretsch (1990), who collected a comprehensive list of innovations
introduced by business firms during the year 1982. Over 85 per cent of
the innovations they identified were modest improvements to existing
products, and none created entire new markets. Fewer than 2 per cent
? Oslo Manual (Tanaka et al., 2005), third edition, p. 46.
36 International context
were considered even the first of its type on the market in existing
market categories.®
The NSF has recently redesigned the industrial R&D survey and
renamed it the Business R&D and Innovation Survey (US-NSF, 2009).
In doing the redesign, they added a pilot question on innovation similar
to those in the European CIS (Community Innovation Survey) in 2008:
Did your company introduce any of the following during the
three-year period, 2006 to 2008?
1. New or significantly improved goods (excluding the
simple resale of new goods purchased from others and
changes of a solely aesthetic nature).
2. New or significantly improved services.
3. New or significantly improved methods of manufactur-
ing or producing goods or services.
4. New or significantly improved logistics, delivery, or
dis
ribution methods for your inputs, goods, or services.
5. New or significantly improved support activities for
your processes, such as maintenance systems or opera-
tions for purchasing, accounting, or computing.
Unfortunately, for a number of reasons, including survey design, cover-
age, and nonresponse, the results from the pilot question cannot really
be compared with those from other countries (Hall, 2011; Jankowski,
2012). In response to the problems they encountered with this first
trial, the NSF redesigned the survey in the following year, moving the
innovation question to the front of the survey and adding several other
questions, but the data for 2009 and 2010 have not yet been released so
that we are unable to use them in this report. Preliminary numbers in
Jankowski (forthcoming, 2013) suggest that the U.S. innovation rates
5 Note that by using the 1982 date, Acs and Audretsch did miss two major
innovations: the IBM personal computer and Microsoft DOS, both of which were
introduced in 1981 and which arguably meet the definition of “created entire new
market”.
Innovation surveys 37
are still substantially lower than those for European countries, but
issues of firm size and sector coverage comparability still remain.
The innovation data produced by the European CIS have been
widely used by economists in models of R&D, innovation, and produc-
tivity, so we have learned something about their quality (Mairesse and
Mohnen, 2010). The main variables used have been the binary indicators
for product and process innovation at the firm level. Although they
are clearly related to the conduct of R&D in the data (especially in
the manufacturing sector), they are also very noisy indicators of the
underlying innovation concept.* Given a choice between the amount of
R&D spending, or a binary innovation indicator to predict productivity
growth at the firm level, the estimation models clearly prefer R&D
spending as an explanatory variable, when it is available. However,
ince many innovating firms do not report that they do any R&D, the
innovation indicator can still be useful.
A simple thought experiment will demonstrate why
tion indicator has limitations: imagine comparing the answers given by
a binary innova-
a micro enterprise and a large multinational to the question of whether
they have introduced a new product or process during the past three
years. Clearly, if the large multinational answered no, we would be wor-
ried about i
irvival, whereas it might be perfectly normal for a small
enterprise to innovate, but possibly not at less than three year intervals.
But have we learned that the small enterprise is less innovative than
the very large one? Not necessarily. In contrast, R&D is a continuous
variable that can be transformed into the intensity with which a firm
| innovation.
invests in technologic
Alternatively, consider comparing two larger enterprises, both of
which introduce a new product, but one of them captures the market,
and the second enters a market new to it and fails to get more than
small share, while remaining profitable due to its old products. Both will
be recorded as innovative, but the result is clearly quite different. The
amount they earn from innovation as a share of sales would be a lot more
4 Hall et al. (2013) report that in the UK, the share of service sector innovating
firms that do not do any type of R&D (including external, capital equipment for
new process, and training) is about twice that in the manufacturing sector.
38 International context
informative. In the case of product innovation, fortunately the share of
sales due to new products has been collected by the CIS (and will be
collected in future U.S. surveys) and this has turned out to be a better
predictor of productivity than the simple binary variable, especially
in the absence of a measure of spending on innovation. It would be
desirable to try to collect a similar measure for process innovation.® If
one cannot obtain estimated cost reduction from this kind of innovation,
it might be possible to use measures of investments in new capital and
training that are associated with the introduction of new processes.
All this suggests a couple of ways that innovation surv
improved to capture a full picture of firm innovative activity. Some of
these have already been discussed in the Oslo Manual, but have not been
incorporated into most innovation surveys. The first would be a focus
vs could be
on trying to measure the benefits of process or organizational innovation
in a more quantitative way. For this purpose, the Oslo Manual suggests
first asking whether the innovation led to a reduction in cost, and then
asking by how much:
“These questions can either be asked with respect to average
costs or to specific costs, for example changes in the cost of
material, energy or labour inputs. Quantitative questions
ntage
an either ask for an interval estimate of the per
change in costs; or ask enterprises to choose from. setof
predefined categories (e.g, an increase or decrease of less than
5%, 5% to 25%, over 25%). Experience from earlier surveys
indicates that enterprises find the latter method easier to
answer and thus results in much higher item response rates.
The same techniques can also be used to ask about the
ss innovations on employment, i.e. whether
employment increased or decreased, and by how much.” (Oslo
Manual, third edition, page 111).
effect of proce:
A second area where more information than currently available
would be helpful is expansion of the information collected on innovation
expenditures (question 5.2 on the standard CIS questionnaire). Currently
§Pet
on such an effort in Germany.
2006) repor
(2006) rer
Innovation surveys 39
some but not all of the innovation surveys in Europe collect information
on the following categories of expenditure:
« In-house R&D - including software development in-house
e External R&D - performed by other enterprises (including other
enterprises or subsidiaries within your group) or by public or
private research organisations and purchased by your enterprise
© Acquisition of machinery, equipment and software used to produce
new or significantly improved products and pre
nesses
© Acquisition of external knowledge - Purchase or licensing of patents
and non-patented inventions, know-how, and other types of knowl
edge from othe anisations for the development
of new or significantly improved products and proc
enterprises or or;
S
oT
specifically for the development and/or introduction of new or
significantly improved products and proc
ining for innovative activities - Internal or external training
38e8
e Market introduction of innovations, including market research
and launch advertising
Design - to improve or change the shape or appearance of new or
significantly improved goods or services
e Other - Other activities to implement new or significantly im-
proved products and processes such as feasibility studies, testing,
routine software development, tooling up, industrial engineering,
etc.
In some cases only a yes/no answer is required for the above in the
current surveys, but the data would be considerably more useful if
actual expenditure data can be collected.
A final suggestion for additional data that might help correct the
bias introduced by sectoral variation in the meaning of a new product
also comes from the Oslo Manual:
40 International context
“In order to take into account the effects of product life on
this indicator [the introduction of a new good or service in
the past three years], it is suggested that the firm should
be asked to give an estimate of the average length of its
products’ life cycles. This information could be used to
weight the percentage shares suggested above. An alternative
way of putting this question is to ask how often the firm
usually introduces innovations.” (Oslo Manual, third edition,
page 110).
We have not found any evidence that this question has ever been at-
tempted in an actual innovation survey, so it is hard to evaluate whether
the answers would be helpful. However it does see worth considering as
an indicator that would help interpretation of the innovation indicators
themselves.
Other innovation indicator efforts
In this section we catalogue a few other efforts toward constructing
innovation indicators, by the World Bank, the UK government, and a
research institute in Germany, the Deutsche Institut fiir Wirtschafts-
forschung (DIW).
World Bank
KAM is the Knowledge Assessment Methodology developed by the
World Bank, which consists of 4 pillars:®
e Economic Incentive and Institutional Regime
Education
e Innovation
e Information and Communications Technologies
© http:
/www.worldbank.org/kam
Other innovation indicator efforts 41
From these pillars, each of which contains a number of individual
measures, they produce two indices: a Knowledge Index (KI) and a
Knowledge Economy Index (KEI). The Knowledge Index
education, innovation and ICT investment. The Knowledge Economy
based on
Index adds the economic incentive and institutional regime pillar to
this.
As is clear from the website, these measures are primarily input and
institutional measures, describing the framework in which the knowledge
economy can grow, and intended as a diagnostic and benchmarking
tool for the World Bank client countries. The website provides a range
of different “scorecards,” including custom combinations of indicators,
that can be consulted by policymakers.
UK NESTA (for the UK Dept of Business, Innovation, and Skills)
A study of wider frameworks for innovation (Allman et al., 2011). This
study focuses to some extent on indicators that are designed to me
sure
UK underperformance in innovation environment such as fear of failure,
ICT take-up, etc. They divide indicators into
entrepreneurial activity
five categories and produce a long list of indicators for each one:
e Public research base and linkage to industry
e Demand conditions and competition
e Supply of high quality human resources and finance
e Infrastructure and services in the economy
e Degree of entrepreneurship
Among the detailed lists that they give, these indicators are already
present in most collections:
e Gross Expenditure on Research and Development
e Share of GBAORD as per cent of total general government expen-
diture
42
according to the areas about whic!
International context
© [Higher Education R&D as percentage of GDP
e Percentage of BERD financed by abroad
e Percentage of BERD financed by the government
e Percentage of HERD financed by the private sector
e Publications per 100,000 population
e Publications per million dollars
e Average annual citations per HERD Expenditure
e Patents, Invention Disclosures and Licenses
e Sources of Universities Research Income
e Firms with new-to-market product innovations by size
Patents and trademarks per capita, 2005-07
e Number of scientific & technical articles cited in patents
e Citations to academic patents
e Market Capitalisation of listed companies (percentage of GDP)
Venture capital investment as a percentage of GDP by early stage
and expansion
e Share of employment in KIBS, 2009 54
e Education expenditure and performance
e Human resources in science and technology as a share of labour
force (%)
e Costs of firm entry
The indicators below are potentially new. We have grouped them
they provide information.
Other innovation indicator efforts 43
End-user demand for innovation (consumers):
Interest in new inventions and technologies
Sonsumer Confidence Index
Buyer sophistication: ability of buyers to understand innovation
and use it
Final consumption expenditure of households: communication
share
End-user demand for innovation (firms):
Government procurement of advanced technology products
Value of public procurement which is openly advertised as a % of
GDP
Firm-level technology absorption
Cooperation with clients
Intensity of local competition
Startups and firm growth:
Births, Deaths and Active Stock indicator
Employer enterprise birth and death rates
Fear of failure rate
Early-stage entrepreneurial activity distinguishing necessity and
opportunity
High-growth early stage entrepreneurial activity
Global market penetration by SMEs
Cost of ac to IPR servic
44 International context
Financing:
e Ease of access to loans
¢ Venture capital availability
e Ease of access to local equity markets
Labor markets:
¢ Employment in creative sectors as a share of employment
Individuals’ level of computer and internet skills
Life-long learning
Workforce development indicators (firm-level OJT, ete.)
Choice, discretion and creativity at work (survey)
e Share of firms with co-operation agreements with government or
higher education
Diffusion of new technologies
¢ Business use of mobile internet
3G (and higher) coverage
3G or higher cellular mobile adoption
e c-Intensity Index (Boston Consulting Group — weighted sum of
a nation’s supply of Internet infrastructure and the demand for
Internet services)
e Business use of social networking
The above lists are very comprehensive and it is not at all clear
that it is even feasible to collect many of the measures, or that all of
them would add information to what we already know. However, some
of them have the potential to be useful, especially those focused on.
demand side considerations and diffusion, neither of which are especially
well-measured in our current set of indicators.
Other innovation indicator efforts 45
Deutsche Institut fiir Wirtschaftsforschung (DIW)
Belitz et al. (2011) describe an effort by the DIW in which they computed
a composite indicator for 13 EU countries, Japan, Korea, the US, and
Canada and do some sensitivity analysis. Unfortunately they are not very
specific about which measures they use and how exactly the variables
are measured. The subindicator components are the following:
e Education
— Costs
— Output in terms of grads
— PISA scores
Lifelong learning
e R&D
— Spending
— Patents
— Publications & citations
e Financing
~ General financing conditions
— Financing of startups
— Publie R&D support
Tax policy
e Demand
— GDP per capita
— Domestic demand for innovative products
~ Measures of buyer’s sophistication, firm level technology
absorption and government procurement of advanced tech-
nology products
46 International context
Networking
— degree of inter-company networking
— alliances with suppliers and customers
~— R&D cooperation, esp. internationally
e Implementation
— Research intensive VA and employment, balance of payments
— Valuations of Transport and Energy systems, Network Readi-
ness and E-Readiness
¢ Competition
— Product Market Regulation (PMR) index of the OECD
— Measures of competition and corruption fighting
© Socictal innovation climate
— World Value Survey Data for openness to new technologies
and formation of social capital
~ Eurobarometer Data for trust measures and concerns about
science and technology.
5
STI indicators for STI policy
As noted above, indicators are desired to some extent merely for the
purpose of a scorecard or benchmarking of the level of activity in
different areas. And it is important for the advance of social science
that the data underlying STI indicators be available. But consistent
with the idea of “The Science of Science
and Innovation Policy,” it is
also desirable for the indicators to be as helpful as possible in informing
major public policy decisions. In this section, we survey briefly how
indicators can (and often cannot) meaningfully inform policy choices.
Overall level of public investment in R&D. Implicitly, the Congress
and the President are continuously deciding what overall level of re-
sources to invest in new knowledge creation through the R&D process.
Ideally, this would be informed by data showing the marginal rate of
return on these investments. But marginal rates of return are very
difficult to measure. Economists and others have made estimates of the
average rate of return to R&D investments (Hall e¢ al., 2010). Within
the model, the marginal rate of return declines with the intensity of
R&D investment (R&D/GDP) other things equal, so a high average rate
of return is a neces
ry but not sufficient condition to justify increased
investment.
AT
48 STI indicators for STI policy
In the absence of explicit information, R&D intensity measures do
e of return. Economic models
provide some implicit evidence on the r
typically presume that there are diminishing returns to increased R&D
expenditure, so that the rate of return to R&D will fall as R&D/GDP
s. This means that if today’s U.S. R&D/GDP ratio is lower than at
another point in time, we may be able to infer that the rate of return in
rise
the U.S. today is higher than it was at that point of time, assuming that
nothing else has changed. The same argument applies when comparing
R&D intensities across countries, although it is even more difficult to
assume that other things are equal in that case. Thus if we have some
reason to believe that the investment level was right at some point in
time, then we might be able to infer that the implied high rate of return
in the U.S. today justifies a higher level of investment (and vice versa if
today’s U.S R&D intensity is higher than at some other time or place).
However, given all the uncertainties, it would probably be better to
attempt to measure the return to R&D spending in this case.
Overall level of public investment in education and training. The
issues with respect to the optimal level of investment in education and
training are analogous to those related to R&D. We would, ideally, like
to have measures of the rate of return; measures of the current ratio
of investment to GDP may provide indirect evidence on the rate of
return, at least relative to other times or places. In addition, public
policy may view having an educated public as a desirable end in itself,
over and above any return it may provide in terms of innovation and
technology. If so, then data on years of schooling and degrees awarded
are useful policy indi:
ators independent of their indirect implications
for the economic rate of return.
Educe
different contexts. We have better data on what occurs in formal educa-
tion and training also take many forms and occur in many
tional institutions than we have on training that occurs on the job, or
is otherwise provided by firms without recourse to formal educational
institutions.
Allocation of both of above by scientific/technical area or area of ul-
timate application. Even more than the overall determination of pub-
STI indicators for STI policy 49
lic investment, the government must continuously decide the allocation
of public resources for R&D and education/training across scientific and
areas of application. Again, within the model
ions would be the marginal
nical fields, and a
the most relevant information for these de:
rates of return. And again, these are hard to measure, and measurements
of average rates of retwn are incomplete as indicators of marginal rates.
In addition, there are substantial spillovers across scientific fields (e.
the importance of computer science for DNA analysis) so that localized
rates of return may not capture the true importance of some fields.
The relevance of inv
stment intensity measures as indirect indi
a-
tions of marginal rates of return is more complex in the context of
allocation across fields or sectors. If the inherent technological opportu-
ni
y is greater in a given sector, then its marginal returns are higher at
any given level of investment. Thus it is possible, for example, that our
much higher level of public investment in research in health sciences
than in other fields represents an implicit belief that technological op-
portunity, and hence marginal returns, are higher in that area than in
others. On the other hand, no other country in the world devotes such
arch investment to health sciences. Unless
a large share of its public re
the variation of technological opportunity across fields is different in
different countries, comparative benchmarking on sectoral allocations
may provide indirect evidence on rates of return. As noted above, how-
ever, this is a particularly problematic sector due to the difficulty of
measuring output properly and the fact that health improvements are
not completely capture by national income accounts.
Allocation of federal R&D and training resources by types o'
ns (e.g. intramural versus extramural or universities versus
Allocation of public resources across different kinds of institutions ra:
es
the same issue of relative rates of return as allocation across sectors. In
y different roles in the STI
ators reflecting intermediate outputs of the re
addition, different kinds of institutions ple
tem. Hence indi arch
process, and flows of knowledge within the system, might be informative
about imbalances within the system. It would also be useful to construct
and publicize more detailed statistics on the demand for S&T skills in
certain areas, including starting salaries, in a timely manner.
50 STI indicators for STI policy
Science and technology policy choices other than spending. Many
government policy choices explicitly or implicitly affect the STI
tem,
including R&D subsidies (and other tax policies), intellectual property
sms for the transmittal of funds (e.g. basic
grants, contract research, prizes, etc.). It is not cl
as we normally think of them, shed light on the relative efficacy of
different policy choices of this kind. But the data collected as the basis
search
rules, and mechan:
ar that indicators,
for indicators can also be used by social scientists to study the relative
effectiveness of different mechanisms. In fact, these data are essential
for this purpose.
Immigration policy (as applied to scientific/technical workers). In-
dicators related to the number of number of scientific and technical
workers, combined with the level of investment in research, may be
useful for informing the nature and extent of visa programs to allow
more technically trained immigrants to work in the U.S.
Indicators for use by university administrators or firm managers?
rators face many of the same
Firm managers and university adminis
choices as governments: how much to spend and what to spend it on.
Many of them rely to some extent on benchmarking, that is, observing
Therefore the
the spending patterns of their immediate competito’
same kinds of data as described above can be useful, preferably broken
down by sector and by geography.
6
Issues and Gaps in existing U. S. indicators
In this section we identify a few broad areas where consideration of the
STI framework relative to the existing indicators, and learning from data
collection efforts in other countries, suggest areas for possible expansion
and improvement of U.S. indicators. In the Concluding Section, we
move to a broader examination of STI indicators relative to the Key
Issues and Questions identified by the Panel in their Interim Report.
Innovation measures
As discussed above, the Europeans have pioneered the collection of data
on innovation through the implementation of the Oslo manual. The new
BRDIS surveys already administered for 2009 and 2010 should give us
more information on this activity. Unlike the 2008 survey, these surveys
n with a page of questions about innovative a
including the
following:
1. Whether the firm introduced
(a) new or significantly improved goods
(b) new or significantly improved services
51
52 Issues and Gaps in existing U. S. indicators
(c) new or significantly improved methods of produc-
tion
(d) new or significantly improved logistics, delivery, or
distribution methods
(ec) new or significantly improved support activities
2. Was any of the above new to the market or only new
to the firm.
3. Give percentages of sales due to 1) goods & services
new to the market; 2) good & services new to the firm
only; 3) goods & services that are not new. Must add
to 100%.
As discussed above, existing analyses of data from the European surveys
suggests that yes/no answers to the innovation question in (1) create
very coarse indicators that provide very weak measurements of the
impact of innovation on such things as productivity. Question 3 is more
promising in this r
for the innovations corresponding to questions la and 1b. This survey
ard, but it provides quantitative impact data only
will not collect any information about the cost-savings and employment
changes from the kinds of innovations covered by le, 1d, & le. Given the
importance of these innovative activities in service-related sectors and
non-R&D innovation, future work might want to explore improving the
measurement of the benefits of process and organizational innovation. As
useful to add a ve
discussed below, it would also be ver) ion of question
5.2 from the CIS (non-R&D expenditures on innovative activities) to
the BRDIS survey.
Innovation in the service sector
There is no doubt that the service sector (broadly defined) is an increas-
ingly important part of most developed economies: in the U.S., sectors
producing services now account for 69% of private non-agricultural em-
ployment and 69% of value added in GDP as compared to 9% and 17%
1 The way this question is posed might have been confusing if the firm answered
yes to more than one item in (1).
Innovation in the service sector 53
respectively for the goods-producing sectors including manufacturing.”
However, historically US data collection efforts related to innovative
activity have focu:
tor has been more important in economic terms than manufacturing
for some time.
ed on manufacturing, even though the serv
3 To some extent, the focus on manufacturing reflects
a traditional science and technology view of innovative activity, one
that centers on organized R&D laboratories and research employees.
In the service sector, much of the effort at knowledge creation and
innovation does not occur in organized research labs, and is undertaken
by employees who are not categorized as researchers, making it harder
tom innovation effort.4
sure
As services have become more important to the economy, and their
innovative activity more obvious, it has become clear that more effort
needs to be focused on data collection in serv
R&D is a less useful measure of innovative investment. One can get a
ces, Where spending on
rough idea of the importance of innovation in the service sector from the
results of the CIS surveys in the European Union.° In 2005, 39% of firms
in th her a
manufacturing sector reported that they had introduce
product or process innovation (or both). For the service sector as a whole,
Report of the President (2011), Tables B-12 and B-46. The service-
producing sectors includes utilities, wholesale trade, retail trade, transportation
chousing, information, finance, insurance, real estate, rental, and lea:
nd business services, education: health care, and social
s, entertainment, recreation, accommoda
vices, except government.
8 B.g., see the historical NSF s
and
servic
tion, and food services, and
atistics on R&D spending by sector, which reflect
the bias toward manufacturing in the sampling frame during earlier years. In 1992,
the non-manufacturing sector was reported as responsible for 25 per cent of R&D
spending, whereas in 1980, only 4 per cent. These numbers are unlikely to accurate
reflect the actual increase in spending among the non-manufacturing firms, due to
changes in the sampling frame used for the RD-1 survey. For more information, see
http://www.nsf.gov/statistics/s2194/conten3a.htm
* This issue is not limited to the service sector. Even in manufacturing, some
rch effort occurs outside of laboratories, perhaps increasingly so and these
» harder to measure.
published results from the NS: 008 BRDIS survey
(US-NSF, 2010) are not complete enough to report exactly similar numbers for the
United States, although it does appear that while innovation rates are lower in
services than in manufacturing, in some KIBS they are much higher (e.g., software).
54 Issues and Gaps in existing U. S. indicators
the number was 34%, whereas for knowledge-intensive business sectors
(KIBS) it was 52%.° These numbers clearly suggest the importance of
tion efforts. One
would be even higher in the United
apturing this activity by broadening of data colle
could argue that these numbe
States, which has been a leader in ICT-related proc
reorganization
and in the production of information services.
Thinking about important innovations in the service sector during
the past few decades, we can see that many of them have been driven by
the availability of networked computer and communication technologies:
e.g., online reservation, ticketing, and load management systems in
airlines, the growth of the logistics industry (Federal Express, DHL,
UPS, and so forth); management of inventory systems that span regions
or count:
suggests that innovation in this sector is frequently proc
where changes in process may lead to new and improved produc
without explicit spending on R&D, and that one useful measure might
be the level of investment in new ICT hardware and software. This view
ies; financial innovation of various kinds. Thus past history
s-oriented,
is supported by the UK data cited earlier (Hughes and Mina, 2012),
where the acquisition of innovation-related machinery, equipment, and
software in the service sector ranges anywhere from 30 to 90 percent of
innovation expenditure, depending on the sector.
Data from the service sector can also be helpful in informing us
about the pricing of certain kinds of research output. In particular, the
R&D services sector sells its output on the market to other industrial
sectors, as does the computing software sector. Given the difficulty of
constructing price deflators for intangible outputs like R&D and software,
data on production in these sectors may be useful (see Corrado et al.,
2011 for a new attempt to construct an R&D deflator).
° Manufacturing is defined as usual (NACE sector D). The servi ctor excluding
KIBS covers Wholesale trade, Transport, storage & communications, Financial
intermediation, Real estate, renting and business activities (excluding those in KIBS).
KIBS includes Computer and related activities, R&D services, Architectural and
engineering activities, and Technical testing and services.
Non-R&D investment that fosters innovation 55
Non-R&D investment that fosters innovation
In addition to expanding data collection on innovative activity and
innovation, it would also be useful to have more information on the
inputs to the innovation process that do not fall under the rubric of
R&D and hence are not captured systematically by existing surveys in
the U.S. These include:
© Acquisition of machinery, equipment and software used to produce
new or significantly improved products and processes
Training for innovative activities - Internal or external training
specifically for the development and/or introduction of new or
significantly improved produc
a
s and. processes
e Design - to improve or change the shape or appearance of new or
significantly improved goods or services
The overall significance of these non-R&D forms of STI investment is
difficult to assess, but they are clearly important, at least in some sectors.
Hughes and Mina (2012, Figure 3) present data on the distribution
of these forms of investment a for the UK. Overall the
two largest. categories of spending in their figure are internal R&D and
capital equipment. The share of innovation expenditure that is internal
tor:
‘OSS St
and external R&D is above 50 per cent only in computing, technical
testing and analysis, motion picture and video production, R&D services,
and the manufacture of electrical and optical equipment. In many other
sectors, including financial intermediation, telecommunications, retail
trade and repair, construction, mining, and post & courier activities,
the bulk of innovation spending is on the acquisition of machinery,
equipment, and software related to innovation. So if we ask what we
are missing when we only collect R&D spending data, clearly the most
important omission is the purchase of (possibly R&D-intensive) goods
from other firms that are used for innovation in the purchasing firms.
‘As can be seen in Table One, our data related to the accumulation of
human capital all relate to education and training in the education sector.
But
and other workers also accumulate human
ientists, enginee
56 Issues and Gaps in existing U. S. indicators
capital on the job. Current indicators do include data on scientists
and engineers engaged in work-related training, but these data are not
connected to the innovation process. This will be particularly important
with respect to the introduction and diffusion of new technologies, which
may require knowledge and skills that current workers do not possess.
Non-R&D related innovation includes a great deal of design-related
activity. In fact, judging from the numbers in Hughes and Mina (2012),
design expenditures are relatively more important in several manufac-
turing industries as in the service sector. One way to try to measure
design innovation might be to look at design patenting. At the USPTO,
design patent grants were 5.7 per cent of all patent grants in 1963,
rising to 8.7 per cent in 2011. Thus in spite of the enormous incr
in utility patents during the same period (utility patents grew at 8 per
cent per annum during the same period), design patenting grew even
faster at 13.7 per cent per annum. From these number we can at least
sed in importance.
Ase,
conclude that protecting designs with IPR. has incr
Unfortunately, an extensive search of the economics literature has found
only one study on the use of design patents and firm performance or
innovation.” This study, by Bascavusoglu-Moreau and Tether (2011),
looks at registered design rights and firm performance (measured as
labor productivity) in the UK, finding a positive association prior to
2000, but not after. Unfortunately their analysis is confounded by the
fact that there were substantial changes to the benefits and costs of
design registration in the UK with the introduction of European com-
munity design registration in the early 2000s and by their inability to
control for the use of other (related) IP rights. Nevertheless, the study
is a useful start to this kind of analysis.
Other issues
Timeliness The usefulness of indicators data is limited by the timeli-
ness with which they are made available. As noted above, data from the
2009 and 2010 BRDIS were not available as of early 2012, although as
* There is a literature on design patenting, but it is primarily legal and historical
in nature.
Other issues 57
of the time of this revision (May 2012) they are becoming available in
aggregate form. Results from the 2008 Survey of Doctorate Recipients
were released only in late 2011. Since these data were collected before
s in the fall of 2008, as of now we
have no information about how the Great Recession affected the job
market for S&T degree recipients. Whatever the constraints within the
statistical agencies that produce these delays, they greatly limit the
value of the information for informing policy.
the acceleration of the financial cris
Linkages In order to gain meaningful understanding of the und
lying
processes, it is necessary in many cases to link data from different
sources. For example, in order to understand how human capital created
at universities contributes to productivity growth of firms, we need to
be able to connect the individuals who are granted S&T degrees with
their subsequent employers, and the performance of those firms. To go
a step further, and analyze the return on the public investment that
was made in those degree holders through re
rch and training gi
we need to link the individual degree recipient to the specif
nts,
> grants
that supported her education. Making these linkages, and exploiting
them to test hypotheses and measure returns, is the province of social
science researchers rather than the statistical agencies themselves. But
the researchers need the underlying data to be captured in a way that
identifies the entities involved in a way that permits subsequent linkage.
We have at least one example where a linkage between the Survey
of Earned Doctorates and the firms they went to was performed and
the researcher was then prevented from publishing work based on this
linkage due to NSF concerns about confidentiality. Such a match can
be quite informative about firm needs and the supply if highly trained
personnel and it ought to be possible to use the data statistically
without revealing individual information. The Bureau of the Census
has a great deal of experience with this kind of research now, via the
federal Research Data Centers.
For looking at the sources and outcomes of federally funded research,
the STAR Metrics project, launched by NSF with the cooperation of
NIH, DOE and EPA, is an initial effort to capture information about
all re
sarch grants to universities by these agencies in such a way that
58 Issues and Gaps in existing U. S. indicators
the people involved in the research can subsequently be connected to
their activities (National Academy of Science, 2011, pp. 72-74).
Measures of knowledge advancement in specific policy-relevant ar-
eas The NSF-published indicators do not systematically present data
on publication or patent trends in specific areas of public policy interest,
such as environment, national security or health. The underlying data
exist, however, to prepare such series, based on journal and patent
classifications. Hence this is an example of an area where individual
researchers, supported by public research funding to the extent the
tions are deemed important, can provide the neces:
que ry indicator
series on the basis of data that are available.
Capital available for financing of technology commercialization The
existing indicators provide a wealth of data related to the financing of
research. The only data they include on financing of the commercializa-
tion stage of innovation is on government programs (e.g. SBIR, ATP),
ant gi
to so-called “angel funding,” i.e. private funding of startup or other
small firms by individuals. A recent survey by the OECD (OECD, 2011)
concluded that angel financing is an important source of capital for new
and venture capital funding. This leaves a signifi p with respect
and small firms in most countries, but is difficult to quantify because of
the heterogeneity of institutions and the consequent difficulty of finding
an appropriate target population for data collection.
Exports and imports An important measure of international compet-
itiveness is the trade balance in advanced technology products. But this
is difficult to measure when manufacturing is globalized, as the products
whose profits accrue to U.S. firms may be manufactured and assembled
in more than one country. Ordinarily these firms will use some form
of transfer pricing when they move the components from country to
country. The NSF S&E Indicators 2010 volume presents a number of
high technology trade indicators for the U.S. and the rest of the world
that are mostly derived from U.S. Census data. However it is unclear
to what extent these data allocate the value addition created by these
products correctly, given their multinational origins. The Apple iPod is
Other issues 59
a notorious example of a product whose market price is considerably in
excess of its manufacturing cost (Dedrick et al., 2010). How much of that
value creation is allocated to the U.S. trade balance depends heavily
on how the prices allocate value added among the various component
suppliers and Apple itself.
7
Conclusion
Table 7.1 summarizes the relationship of the existing indicators to the
Key Issues and Questions for STI Indicators put forward in the Interim
Report. In general, the Table shows that the existing indicators do
provide a wealth of information relevant to the key issues, with the
possible exception of “Systemic Changes on the Horizon.” If one looks
more deeply, however, at the specific questions identified in the Table,
it is also clear that the indicators, in and of themselves, do not provide
answers to the questions posed.
In our view, indicators and other data will never, in and of themselves,
provide answers to questions of this kind. The questions posed are, for
the most part, research questions. Answering them requires not just
data but modeling and analysis. Indicators and data more generally
are necessary inputs to the research process that can provide answers
to these questions, but they do not provide the answers without that
analysis.
It is therefore worthwhile to ask to what extent gaps in the existing
data and indicators constitute important barriers to getting the answers
we want. Our view is that, for the most part, the important barriers
are not gaps in the data. In the previous section, we did identify several
60
Conclusion 61
gaps and issues with existing indicators. If these could be addressed,
it would facilitate better analy:
is of the important questions. But at a
macro level, we do know the answers to many of the important questions.
Investment in R&D is a major driver of productivity growth, and the
rate of return to both private and public R&D investments is relatively
high. Despite this relationship being clear on average, innovation is a
very risky process, so that there is a lot of variance in the results of all
innovation efforts. Growth in human capital is a key (perhaps the key)
determinant of growth in income, both for individuals and for society
as a whole.
Note that all of these questions for which we have pretty good
answers are questions about how the world works, not the normative
questions of what we should do to improve STI outcomes. These nor-
mative questions are much harder to answer. For the most part, the
reason why these normative questions are hard to answer has little to
do with STI indicators. First, they often involve value judgments about
the relative value to society of different desirable outcomes, such as
better health and a cl
aner environment. In addition, some of the most
important policy questions relate to the relative effectiveness or effi-
ciency of different policy instruments, e
R&D or grants to unive
R&D tax credits versus public
ities versus funding government R&D labs.
These questions are more answerable in principle than the pure value
questions, but the answers require careful, systematic research rather
than generic data collection. ‘They could be answered if the Congress
and the agencies were interested in systematic program evaluation, and
were willing to allocate money for such evaluation. But they will not be
answered by different STI indicators.
There
s one category of normative questions that does, in principle,
relate to indicators, and that is the allocation of public resources
388
different disciplines or areas of research. Although this contains an
element of pure value judgment, it also clearly depends on the rate
of return to research in different ar
which could theoretically be
observed with ideal indicator
But in reality the incommensurable
nature of research outputs in different areas, combined with the highly
nature of research succ
stochasti
s makes it unlikely that better data
62 Conclusion
is going to provide convincing measures of the differences in rates of
return across fields.
Even if better STI Indi
questions, there remain important improvements (some already under-
way) that the Panel can encourage. As discus
previous section, the most important of these include:
ators will not provide answers to the “big”
ed in more detail in the
e Better sector in R&D and innovation
surveys;
coverage of the service
e Implementation of innovation surveys, with eventual expansion
to include measures of cost savings associated with proces
inno-
vation;
e Collection of information on investments in equipment and soft-
ware in support of innovation;
e Collection of information on design efforts;
e Collection of information on training of employees for diffusion
and adoption of innovations;
e More timely publication of indicators and availability of micro
data to researchers;
e Collection and maintenance of data by grant-making agenci
son
individual grants and researchers in such a way that they can be
linked to other data sources.
Finally, we note again that not all data collection and indicator pub-
lication has to be undertaken by the government. Particularly when
it comes to experimental or innovative use of passive data collection,
individual researchers (typically funded by public research grants) can
in many cases collect and publish the data. So long as adequate res
arch
funding for such efforts is maintained, this is likely to provide for more
extensive and ultimately su
ssful development of new indicators than
ies.! Over
mandating collection of specific data by the government agen
' Such research funding should also come with the clear mandate to make the
data available for subsequent researchers so that the data can be tested and its utility
for other uses explored.
Conclusion 63
time, if particular measures prove useful, it would then be possible to
assimilate them into the arsenal of officially collected and published
statistics,
Conclusion
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8 /
Author Biographies
Bronwyn Hall is Professor of Economics Emerita at the University of
California at Berkeley, Visiting Professor at MPI-Munich, and Research
Associate at the NBER, and IFS-London. She has published numerous
articles on the economics and econometrics of technical change and
innovation and is the editor of the Handbook of the Economics of Inno-
vation in the Elsevier series. Her research includes analysis of the use of
intellectual property systems in developed and developing countries, the
valuation of intangible (knowledge) assets, comparative firm level R&D
investment and innovation studies, measuring the returns to R&D and
innovation, and analysis of technology policies such as R&D sub
and tax incentives. She has made substantial contributions to applied
idies
economic research via the creation of software for econometric estima-
tion and of firm level datasets for the study of innovation, including the
widely used NBER dataset for U.S. patents.
Adam B. Jaffe is Senior Research Associate with Motu Economic
and Public Policy Research in Wellington, New Zealand and Adjunct
Professor with Queensland University of Technology in Brisbane, Aus-
tralia. He served Motu as Director and Senior Fellow 2013-2017. He
73
74 Author Biographies
Chair of
and Sciences at Brandeis
was previously the Fred C. Hecht Professor in Econom
Economics and Dean of the Faculty of Ar
University in Waltham, Massachusetts, U.S.A. Jaffe is the author of two
books — Patents, Citations and Innovations: A Window on the Knowl-
edge Economy (with Manuel Trajtenberg, 2002); and Innovation and Its
Discontents: How Our Broken Patent System is Endangering Innovation
and Progress and What to Do About It (with Josh Lerner, 2004). He
is also the editor (with Ben Jones, 2015) of The Changing Frontier:
Re
Richard Newell and Rob Stavins, “The Induced Innovation Hypothesis
rking Science and Innovation Policy. In 2017, his paper with
and Energy-Saving Technological Change” (1999) won the Association
of Environmental and Resource Economists Award for Publication of
Enduring Qualit
and technology diffusion, particularly as it affects environmental and
Jaffe’s research focuses on technological innovation
energy technologies, and on science and innovation policy.
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